On October 16, 2020 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, reported that it has executed a definitive agreement with the Global Coalition for Adaptive Research (GCAR) to commence Kazia’s participation in the GBM AGILE pivotal study in glioblastoma (Press release, Kazia Therapeutics, OCT 16, 2020, View Source [SID1234568592]). The study will open a new arm with Kazia’s investigational new drug, paxalisib (formerly GDC-0084), and will now move into an operational phase with recruitment of patients to the paxalisib arm expected to begin in Q1 CY2021.

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Key Points

GBM AGILE (NCT03970447) is intended to serve as the pivotal study for registration of paxalisib in key markets
Dr Ingo Mellinghoff (Memorial Sloan Kettering Cancer Center) and Dr Eudocia Q Lee (Dana-Farber Cancer Institute) have been named as Principal Investigators for the paxalisib arm; Dr Timothy Cloughesy (UCLA) is the Principal Investigator for the overall study
Kazia will pay an initial fee of US$ 5 million to GCAR, with further milestone payments payable throughout the course of the study
The duration of paxalisib’s enrollment period in GBM AGILE is expected to total approximately 30 – 36 months, plus follow-up, but will depend on emerging study data, recruitment rates, and other variables
Kazia CEO, Dr James Garner, commented, "we have spent the last nine months or so working closely with the GCAR team to plan paxalisib’s entry into GBM AGILE, and we are very gratified to now be moving into the operational phase of the study. GBM AGILE is truly a ground-breaking clinical trial, driven by some of the world’s leading experts in the field, and we are proud to be a part of it. We expect GBM AGILE to provide definitive clinical evidence for the approval of paxalisib by regulatory agencies in key markets. This is a faster, more cost effective, and higher quality study than any company of our size could mount independently, and we are confident that it will provide the best possible opportunity for paxalisib to demonstrate its potential in this very challenging disease."

Dr Meredith Buxton, Chief Executive Officer at GCAR added, "We are pleased to welcome paxalisib into GBM AGILE. Our mission is to help drive the development of new therapies for glioblastoma, by creating an efficient model for testing and confirming new potentially beneficial treatments for patients with GBM. We look forward to continuing to work closely with the Kazia team to bring paxalisib into the study and support its evaluation."

Principal Investigators

Dr Ingo Mellinghoff and Dr Eudocia Q Lee will serve as Principal Investigators for the paxalisib arm. Dr Timothy Cloughesy is the Principal Investigator for the overall study.

Dr Mellinghoff is the Chair of the Department of Neurology at Memorial Sloan Kettering Cancer Center in New York, NY. He is a highly experienced neuro-oncologist with an extensive track record of published research in brain tumours, and is a Professor at the Gerstner Sloan Kettering Graduate School of Biomedical Sciences and the Graduate School of Medical Sciences at Weill Cornell University. His laboratory focuses on the study of biochemical pathways that regulate the growth of brain cancer, and he has participated in numerous clinical trials for glioblastoma and other forms of brain cancer.

Dr Mellinghoff commented, "we have seen little progress in the treatment of glioblastoma for over two decades, and the need for new therapies is urgent. We have seen encouraging signals from the paxalisib program thus far, and my colleagues and I look forward to exploring its potential in the GBM AGILE pivotal study."

Dr Lee is a neuro-oncologist at Dana-Farber Cancer Institute in Boston, MA, Director of Clinical Research at the Center for Neuro-Oncology at Dana-Farber, and an Assistant Professor of neurology at Harvard Medical School. She is a widely published clinical researcher, with a primary research interest in tumours of the brain and spinal cord, and their neurologic complications. Dr Lee has been an investigator in previous clinical trials of paxalisib in glioblastoma and has first-hand clinical experience with the drug.

Dr Lee added, "GBM AGILE has been designed to provide a definitive assessment of the efficacy of new drugs for glioblastoma. Paxalisib has already been evaluated in two clinical trials in this disease, and GBM AGILE will now greatly enrich our understanding of how best to use it for the benefit of patients."

GBM AGILE

GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is an international platform study that has been established specifically to facilitate the approval of new medicines for glioblastoma.

The scientific leadership of GBM AGILE comprises many of the leading experts in glioblastoma, and they have worked in collaboration with the US FDA on its development. It is sponsored by the Global Coalition for Adaptive Research (GCAR), a US-based 501(c)(3) non-profit organisation. At present, the study is underway in 30 sites in the United States and Canada, with plans to launch in Europe and China during CY2021. One drug candidate is currently participating, and paxalisib will be the second candidate to join the study.

GBM AGILE is an adaptive study, so the number of patients recruited, and their allocation within the study, will be continuously adjusted in the light of emerging results. It is expected that between 50 and 200 patients will receive paxalisib, depending on the safety and efficacy of the drug. The data from these patients will be compared against data from an estimated several hundred patients in a shared control arm, allowing for considerable operational efficiency.

The paxalisib arm of GBM AGILE will recruit newly diagnosed patients with unmethylated MGMT promotor status, which is the same population that has been investigated in Kazia’s ongoing phase II study. In addition, GBM AGILE will recruit recurrent patients to the paxalisib arm. The drug may ultimately be considered efficacious in either or both of these patient groups, and Kazia will frame any future application for regulatory approval on the basis of this data.

Dr Mellinghoff added, "we see interesting signals of activity in the phase I study of paxalisib in recurrent glioma patients, and so my colleagues and I consider it important to evaluate the drug also in this later-stage group, where the unmet medical need is very substantial. Including both newly diagnosed and recurrent patients in GBM AGILE enables us to observe how paxalisib performs across the spectrum of the disease, and provides us with a significant amount of additional data as we move towards registration."

The primary endpoint of GBM AGILE is overall survival (OS), which is considered the gold standard endpoint for the assessment of new cancer therapies.

Indicative Costs and Timelines

Kazia will initially pay a fee of US$ 5 million to GCAR in consideration for paxalisib joining GBM AGILE. Additional payments will be due throughout the duration of the study, dependent on the attainment of key milestones. The full financial terms of the agreement between Kazia and GCAR are considered commercially confidential. In addition, the total cost of the study will depend on the number of patients ultimately recruited and other operational variables.

Kazia and GCAR expect that necessary regulatory filings and submissions to institutional review boards will be actioned during 4Q CY2020. First patient in to the paxalisib arm is currently anticipated to occur early in CY2021.

The duration of paxalisib’s participation in GBM AGILE is unpredictable due to the adaptive nature of the study. As an indicative base case estimate, Kazia expects at this stage that paxalisib will enrol patients for between 30 – 36 months, plus follow-up. However, this figure could change, either in an upward or downward direction, depending on emerging data from the study as well as operational matters such as recruitment rates.

On October 16, 2020 Photocure ASA (OSE:PHO) reported a highlight from the BLADDR 2020 congress, a poster presentation on new findings from the Nordic Flexible BLC registry, an ongoing prospective multicenter study (Press release, PhotoCure, OCT 16, 2020, View Source [SID1234568591]). It demonstrates that flexible Blue Light Cystoscopy helped resolve a substantial amount of cases by complete removal on-site or direct referral to intravesical treatment, providing increased efficacy to manage non-muscle-invasive bladder cancer (NMIBC) in the office setting.

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The BLADDR congress, held virtually this year, is solely focused on bladder cancer and attracts the interest of experts from all over the world.

"It is encouraging to see how data on the blue light cystoscopy procedure continues to provide new insight into the efficiency of how to manage NMIBC in the office setting. The BLC procedure is a tool that helps physicians solve such cases outside of the OR. Using blue light cystoscopy with Hexvix, they trust their detection capabilities in the office and can treat the lesions immediately, perform confirmatory biopsies or initiate intravesical therapy. Such options are less costly than OR procedures, thus helping to keep costs down for the healthcare system and sparing the patient additional surgical procedures in the OR. This is a clear win-win situation for both patient and healthcare system", says Dan Schneider, President and CEO of Photocure.

Methodology and data from the study:

The Nordic Flexible BLC registry is an ongoing prospective multicenter study initiated to observe the clinical use and explore possible benefits of blue light cystoscopy in the surveillance setting. From five participating sites, 354 patients in follow-up of NMIBC have been included in the study. Data from 462 blue light procedures were included.

In follow-up of NMIBC, in a predominant intermediate and high-risk patient population, this analysis shows how blue light cystoscopy in a surveillance setting helped resolve a substantial amount of cases by complete removal of lesions on-site, or direct referral to intravesical instillation. In 88% of cases where suspicious lesions were seen, no further diagnostic or surgical treatment procedures (TURBT) were needed.

The authors conclude that blue light cystoscopy in the surveillance setting provides increased efficiency to manage NMIBC.

Here is a link to the poster.

Note to editors:

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This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

About Bladder Cancer

Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000 prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000 deaths annually in 2018.1

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with an average of 61% in year one and 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

1 Globocan. Incidence/mortality by population. Available at: View Source
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295-300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC with Hexvix /Cysview improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview /Hexvix directly in the U.S. and the Nordic region and has strategic partnerships for the commercialization of Hexvix/Cysview in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.

On October 16, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company developing simple, easy to use, cost effective blood tests to help diagnose a range of cancers and other diseases in both humans and animals, reported that it is presenting two abstracts with new data on its first product, the Nu.Q Vet Cancer Screening Test, at the 2020 Veterinary Cancer Society (VCS) Virtual Annual Conference, which takes place from Thursday, October 15 through Saturday, October 17 (Press release, VolitionRX, OCT 16, 2020, View Source [SID1234568590]).

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"The data demonstrate that the Nu.Q Vet Cancer Screening Test has a high sensitivity and specificity in relation to both Lymphoma and Hemangiosarcoma detection in a large and varied cohort," said Heather Wilson-Robles, Professor at Texas A&M University, Chief Medical Officer of Volition Veterinary Diagnostics Development LLC, and President-Elect of the VCS. "The results show an Area Under the Curve (AUC) of 87.3% and 97.6%, respectively, for Lymphoma and Hemangiosarcoma.

Dr. Robles added, "These positive findings provide us with real confidence as we move forward towards the launch of our first product, the Nu.Q Vet Cancer Screening Test, anticipated in the coming weeks. Early diagnosis has a huge potential to help improve the treatment and the quality of life for dogs as well as providing valuable additional information to inform the clinical decision-making process."

An interview with Heather Wilson-Robles, Chief Medical Officer of Volition Veterinary Diagnostics Development LLC.

Cancer is the most common cause of death in dogs over the age of two years old in the U.S. and up to 50% of all dogs over the age of 10 develop cancer in their lifetime. Together, Lymphoma and Hemangiosarcoma make up approximately one third of canine cancers. Currently, dogs suspected of having cancer are required to undergo a variety of diagnostic tests that may be expensive, time consuming and/or painful for the animal. The Nu.Q Vet Cancer Screening Test is a low-cost, easy to use ELISA-based screening test that measures and identifies circulating nucleosomes, which are early markers of cancer, from a simple blood sample to enable a streamlined and less invasive diagnostic process.

The studies were carried out at Texas A&M University on 334 samples (Healthy Control n=134, Lymphoma n=127, Hemangiosarcoma n=73) which included a variety of breeds, genders, weights, ages and different cancer stages.

The Abstracts

Characterizing Circulating Nucleosomes in the Plasma of Dogs with Lymphoma
Friday, October 16 at 1:30 p.m. Eastern Time

Characterizing Circulating Nucleosomes in the Plasma of Dogs with Hemangiosarcoma
Saturday, October 17 at 11:15 a.m. Eastern Time

To register for the 2020 Virtual Veterinary Cancer Society Annual Conference please click here.

The abstracts will be posted to the Volition website on Monday October 19.

To learn more about Volition Veterinary and Nu.Q Vet please visit our new webpage at View Source and/or register for Volition’s Capital Markets Day presentation on Tuesday, October 20 at 8:00 a.m. Eastern Time here.

On October 16, 2020 Dren Bio, Inc., a company developing powerful protein-engineering technologies for depletion of cells, protein aggregates and other disease-causing agents, reported the closing of a $60 million Series A investment round (Press release, Dren Bio, OCT 16, 2020, View Source [SID1234568589]). The round was led by SR One and Taiho Ventures, LLC , with participation from existing investors 8VC and Mission BioCapital and new investors including BVF Partners L.P., HBM Healthcare Investments, and Alexandria Venture Investments.

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Dren will utilize the proceeds to advance its two lead programs through early clinical development. Dren’s first program, DR-01, is an antibody-based therapy to treat rare leukemias and lymphomas as well as specific phenotypes of auto-immune disorders. Dren’s second program, DR-02, is an enhanced antibody-based platform to deplete cells and other disease-causing agents through a novel mechanism-of-action.

"Our strategy is to select the appropriate immune cell type to induce potent and measurable therapeutic effects," said Nenad Tomasevic, PhD, Dren’s Chief Executive Officer and co-founder. "The DR-01 program employs enhanced ADCC to eliminate pathologic cells in clearly defined patient populations. Our DR-02 platform engages a different immune effector cell to a target, resulting in immune stimulation and target depletion."

Dr. Tomasevic brings over twenty years of biotech development experience and previously co-founded Allakos, a clinical-stage, publicly-traded company nearing commercialization.

Lewis Lanier, PhD, Chair of Dren’s Scientific Advisory Board, said, "Dren’s therapies are exciting because they offer novel strategies to meet an unmet need in treatment of lymphomas and leukemias and to potentially enhance the potency of T cells in cancer immunotherapy." Dr. Lanier is the Chair of Microbiology and Immunology and the J. Michael Bishop MD Distinguished Professor at UCSF.

"We are impressed by Dren’s progress since the company’s inception in 2019," commented Rajeev Dadoo, Partner at SR One. "The DR-01 program has a clear development path to the clinic, focusing on diseases with no approved therapies."

"In oncology, the DR-02 platform could enable direct and selective depletion of cancer cells accompanied by localized immune stimulation," said Sakae Asanuma, President at Taiho Ventures. "The technology is also demonstrating the potential to eliminate agents in diverse diseases, including infections and protein aggregation. We are proud to recognize Dren’s potential at an early stage and support its success."

Dren previously closed a $6 million Seed Financing in 2019 led by 8VC with participation by Mission BioCapital and prominent industry veterans. "We appreciate the support from Dren’s investors, who to date have committed over $66 million in funding for our programs," said John Wesley, co-founder and Chief Financial Officer. "The goal of our Series A financing is to bring two drug candidates to the clinic."

On October 16, 2020 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy (Press release, Genentech, OCT 16, 2020, View Source [SID1234568588]). Venclexta was previously granted provisional approval in this setting under the FDA’s accelerated approval program in November 2018. Today’s FDA approval converts Venclexta’s accelerated approval in this setting to a full approval.

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"Today’s full approval is supported by the significant results that showed that Venclexta in combination with azacitidine extended overall survival for people with newly diagnosed acute myeloid leukemia who cannot tolerate intensive induction chemotherapy," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "We are very pleased that this application was reviewed under the FDA’s Real-Time Oncology Review pilot and Project Orbis initiative, helping to bring this treatment option more rapidly to patients in the United States and other countries."

The approval is primarily based on the results of two Phase III studies, VIALE-A and VIALE-C. Results of the VIALE-A study, which were published in the New England Journal of Medicine in August 2020, showed Venclexta plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS) compared to azacitidine alone (median OS=14.7 months vs. 9.6 months; HR=0.66; 95% CI: 0.52-0.85; p<0.001). People treated with Venclexta plus azacitidine had significantly higher rates of complete remission (CR) with 37% (95% CI: 31-43) compared to 18% (95% CI: 12-25) in people treated with azacitidine alone (p<0.001). The Venclexta plus azacitidine combination also led to higher rates of CR and CR with partial hematologic recovery (CR + CRh), with the combination showing a CR + CRh of 65% compared to 23% with azacitidine alone (p<0.001). The National Comprehensive Cancer Network (NCCN) guidelines recently recommended Venclexta plus azacitidine as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy. The most frequent serious adverse reactions (≥5%), reported in 83% of people treated with Venclexta plus azacitidine, were low white blood cell count with fever (30%), pneumonia (22%), blood infection (excluding fungal; 19%) and bleeding (6%).

For the VIALE-C study, the approval was based on the rate and duration of CR. Twenty-seven percent (95% CI: 20-35) of people treated with Venclexta plus LDAC achieved a CR (median duration of CR (DOCR)=11.1 months) vs. 7.4% (95% CI: 2.4-16) of people treated with LDAC alone (median DOCR=8.3 months). The median OS for people treated with Venclexta plus LDAC was 7.2 months vs. 4.1 months (HR=0.75; 95% CI: 0.52-1.07; p=0.114) for people treated with LDAC alone. These OS results were not statistically significant. The most frequent serious adverse reactions (≥10%), reported in 65% of people treated with Venclexta plus LDAC, were pneumonia (17%), low white blood cell count with fever (16%), and blood infection (excluding fungal; 12%).

Updated results from additional Phase I/II studies of Venclexta in people with newly diagnosed AML were included in the FDA submissions as supporting data.

"The results of the VIALE-A study reinforce the clinically meaningful benefit of Venclexta plus azacitidine for people newly diagnosed with AML," said Courtney DiNardo, M.D., associate professor of the Department of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. "Based on the results of this study, this treatment regimen represents a significant advance for older AML patients, including higher response rates, greater transfusion independence, longer durations of remission, and ultimately significantly improved overall survival compared to azacitidine alone."

This is the second time that Venclexta has been reviewed under the FDA’s new Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs. The RTOR pilot program explores a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The approval was also granted under the FDA’s recently established Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among multiple regulatory agencies worldwide. Simultaneous applications were submitted to regulators in the United States, Australia, Canada, Brazil and Switzerland under Project Orbis. Additionally, the FDA has granted five Breakthrough Therapy Designations for Venclexta, two of which are for people with previously untreated AML ineligible for intensive chemotherapy.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

About the VIALE-A Study

VIALE-A (NCT02993523) is a Phase III, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of Venclexta (venetoclax) plus azacitidine, a hypomethylating agent, compared to placebo with azacitidine, in 431 people with previously untreated acute myeloid leukemia who are ineligible for intensive chemotherapy. Two-thirds of patients (n=286) received 400 mg Venclexta daily, in combination with azacitidine, and the remaining patients (n=145) received placebo tablets in combination with azacitidine. Patients enrolled in the study had a range of mutational subtypes, including IDH1/2 and FLT3. VIALE-A met its primary and key secondary endpoints.

About the VIALE-C Study

VIALE-C (NCT03069352) is a Phase III, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of Venclexta (venetoclax) plus LDAC, compared to placebo with LDAC, in 211 people with previously untreated acute myeloid leukemia who are ineligible for intensive chemotherapy. Two-thirds of patients (n=143) received 600 mg Venclexta daily in combination with LDAC and the remaining patients (n=68) received placebo in combination with LDAC.

About AML

Acute myeloid leukemia (AML) is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia. In 2020, it is estimated there will be nearly 20,000 new cases of AML diagnosed in the United States. Many AML patients older than age 60 are unable to tolerate intensive induction chemotherapy treatment.

About Venclexta

Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood and other cancers.

In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukemia.

Venclexta Indications

Venclexta is a prescription medicine used:

to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if Venclexta is safe and effective in children.

Important Safety Information

Venclexta can cause serious side effects, including:

Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient’s doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein.

The patient’s doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS.

Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased.

The patient’s doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects.

Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS.

Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects.
Patients must not start new medicines during treatment with Venclexta without first talking with their doctor.
Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they:

Have kidney or liver problems.
Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium.
Have a history of high uric acid levels in the blood or gout.
Are scheduled to receive a vaccine. Patients should not receive a "live vaccine" before, during, or after treatment with Venclexta, until the patient’s doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta.
Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient’s doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away.
Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient’s breast milk. Patients should not breastfeed during treatment with Venclexta. Patients should not breastfeed during treatment and for 1 week after the last dose of Venclexta.
What to avoid while taking Venclexta:

Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood.

Venclexta can cause serious side effects, including:

Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient’s doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient’s doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta.
Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta.

The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet counts; low red blood cell counts; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet.

The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea, diarrhea, low platelet count, constipation, low white blood cell count, fever with low white blood cell count, tiredness, vomiting, swelling of arms, legs, hands, or feet, fever, infection in lungs, shortness of breath, bleeding, low red blood cell count, rash, stomach (abdominal) pain, infection in your blood, muscle and joint pain, dizziness, cough, sore throat, and low blood pressure.

Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.

These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects.

Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please visit View Source for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 2 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit View Source for more information.

About Genentech in Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit View Source