On November 28, 2018 Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN1 (rituximab) for the treatment of adult patients in three indications (Press release, Teva, NOV 28, 2018, View Source;p=RssLanding&cat=news&id=2378590 [SID1234531715]):

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Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (NHL) as a single agent.
Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
"The approval of TRUXIMA is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication," said Woosung Kee, Chief Executive Officer of Celltrion. "TRUXIMA is the very first rituximab biosimilar to be approved in the United States for three non-Hodgkin’s lymphoma indications and may help provide greater accessibility for patients."

The FDA approval is based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. The totality of evidence submitted for TRUXIMA demonstrated that there were no clinically meaningful differences in purity, potency and safety between TRUXIMA and RITUXAN for the three indications.

"This is an exciting time to be involved in the biosimilars space and we look forward to bringing the product to market," said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. "There is a stronger focus than ever, particularly within oncology, on bringing greater value to the healthcare system through biosimilars increasing the number of treatment options."

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy.

Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize TRUXIMA in the U.S. and Canada. Teva and Celltrion have reached a settlement agreement with Genentech, including entry terms. The terms and conditions of that agreement are confidential at this time.

Important Safety Information

WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion Reactions – Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion reactions

Severe Mucocutaneous Reactions – Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation – HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab product

Infusion Reactions – Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product -induced infusion reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.

Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed. Depending on the severity of the infusion reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3)

Severe Mucocutaneous Reactions – Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with TRUXIMA. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of TRUXIMA to patients with severe mucocutaneous reactions has not been determined.

Hepatitis B Virus Reactivation – Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur.

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment.

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy.

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

Progressive Multifocal Leukoencephalopathy (PML) – JC virus infection resulting in PML and JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture.

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Tumor Lysis Syndrome (TLS) – Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells ( ≥25,000/mm3) or high tumor burden, confers a greater risk of TLS.

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

Infections – Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections.

Cardiovascular Adverse Reactions – Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

Renal Toxicity – Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and a rituximab product is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria.

Bowel Obstruction and Perforation – Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

Immunization – The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

Embryo-Fetal Toxicity – Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA.

Most common adverse reactions in clinical trials of NHL (≥25%) were: infusion reactions, fever, lymphopenia, chills, infection and asthenia

Nursing Mothers

There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants.

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1 RITUXAN is a registered trademark of Biogen MA Inc.

On November 28, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it launched the antitumor agent trastuzumab BS for intravenous drip infusions 60 mg and 150 mg "Daiichi Sankyo" (generic name: trastuzumab (genetical recombination)[trastuzumab biosimilar 2], hereafter, "the product") in Japan today (Press release, Daiichi Sankyo, NOV 28, 2018, View Source [SID1234531676]).

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The product is a pharmaceutical agent developed by Amgen Inc. (Headquarters: Thousand Oaks, CA, U.S.A; hereafter, "Amgen") as a biosimilar product to the anti-HER2 antibody, trastuzumab. The product was approved on September 21, 2018, and indicated for breast cancer with HER2 overexpression (Dosage A), and unresectable advanced or relapsed gastric cancer with HER2 overexpression (Dosage B).

Based on the exclusive agreement on the commercialization of biosimilars concluded with Amgen in July 2016, Daiichi Sankyo is responsible for the distribution and commercialization of the product in Japan, while Amgen is responsible for its manufacture.

The product is the first biosimilar product launched by Daiichi Sankyo, and the company expects that the product will provide patients and medical professionals with various options for cancer treatment, thereby further contributing to medical treatment.

Product name

Trastuzumab BS for intravenous drip infusions 60 mg and 150 mg "Daiichi Sankyo"

Generic name

Trastuzumab (Genetical Recombination)[Trastuzumab Biosimilar 2]

Indications

Breast cancer with HER2 overexpression

Unresectable advanced or recurrent gastric cancer with HER2 overexpression

Dosage and administration

・Dosage A is applied for breast cancer with HER2 overexpression.

・Dosage B in combination with other antineoplastic agents is applied for unresectable advanced or recurrent gastric cancer with HER2 overexpression.

Dosage A: In adults 4 mg/kg (body weight) trastuzumab (recombinant) [biosimilar 2 of trastuzumab] is intravenously infused once daily at the first administration, and 2 mg/kg for 90 minutes or longer at one-week intervals for the second and subsequent treatments.

Dosage B: In adults 8 mg/kg (body weight) trastuzumab (recombinant) [generic product 2 of trastuzumab] is intravenously infused once daily at the first administration, and 6 mg/kg for 90 minutes or longer at three-week intervals for the second and subsequent treatments.

If the initial dose is well tolerated, the administration time can be shortened up to 30 minutes for the second and subsequent treatments.

Date of approval for manufacturing and marketing

September 21, 2018

Date of listing in the NHI reimbursement

November 28, 2018

Day of launch

November 28, 2018

Marketing authorization holder

DAIICHI SANKYO COMPANY, LIMITED

Partner

Amgen Inc.

On November 28, 2018 the U.S. Food and Drug Administration approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma.

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"As part of the FDA’s Biosimilars Action Plan we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive. Our goal is to promote competition that can expand patient access to important medicines," said FDA Commissioner Scott Gottlieb, M.D. "The Truxima approval is our third biosimiliar approval in the past month. The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval."

Truxima is indicated for the treatment of adult patients with:

Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and
Non-progressing (including stable disease), low-grade, CD20­ positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.

Biological products are generally large, complex molecules and may be produced through biotechnology in a living system, such as a microorganism, plant cell or animal cell. A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

The FDA’s approval of Truxima is based on a review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrates Truxima is biosimilar to Rituxan. Truxima has been approved as a biosimilar, not as an interchangeable product.

The most common side effects of Truxima are infusion reactions, fever, abnormally low level of lymphocytes in the blood (lymphopenia), chills, infection and weakness (asthenia). Health care providers are advised to monitor patients for tumor lysis syndrome (a complication of treatment where tumor cells are killed off at the same time and released into the bloodstream), cardiac adverse reactions, damage to kidneys (renal toxicity), and bowel obstruction and perforation. Patients should not receive vaccinations while in treatment. Women who are pregnant or breastfeeding should not take Truxima because it may cause harm to a developing fetus or newborn baby.

Like Rituxan, the labeling for Truxima contains a Boxed Warning to alert health care professionals and patients about increased risks of the following: fatal infusion reactions, severe skin and mouth reactions, some with fatal outcomes; Hepatitis B virus reactivation, that may cause serious liver problems including liver failure and death; and Progressive Multifocal Leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death. This product must be dispensed with a patient Medication Guide that provides important information about the drug’s uses and risks.

The FDA granted approval of Truxima to Celltrion. Rituxan was approved in November 1997 and is manufactured by Genentech.

With the Truxima approval, the FDA has approved 15 biosimiliars. On Oct. 30, 2018, the FDA approved Hyrimoz (adalimumab-adaz), from Sandoz, as a biosimilar to Humira (adalimumab) and on Nov. 2, 2018, the FDA approved Udenyca (pegfilgrastim-cbqv) from Coherus, as a biosimilar to Neulasta (pegfilgrastim).

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On November 28, 2018 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported an update on its late-stage clinical development program for the Company’s proprietary galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, NOV 28, 2018, View Source [SID1234531677]).

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Following a clinical and regulatory strategy defining Type C dialogue with the U.S. Food and Drug Administration (FDA), the Company plans to proceed with a clinical study design and biostatistical plan to support a Phase 3 registrational study for maintenance therapy for AML patients who have achieved complete remission after second line (salvage) antileukemic therapy, or CR2. This study will be used as the basis for a Biologics License Application (BLA) submission, subject to results that are both statistically significant and reflective of an effect of sufficient magnitude to be clinically meaningful.

"Following discussion with the FDA, we are embarking upon a revised Phase 3 study for GPS in the monotherapy maintenance setting for AML patients who have achieved CR2. The new design is expected to streamline sample size, time to accrual completion, primary endpoint readout and potential time to market, as well as costs. We believe this new study design provides SELLAS with a quicker path to approval, provided the study is positive," said Dr. Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "In addition to a statistical analysis plan which we believe accords a viable pathway for meeting the primary endpoint, we have built in an adaptive design, thus further enhancing the probability of a positive study."

GPS was previously given fast track and orphan drug designations in AML by the FDA.

The planned Phase 3 registrational study will be a 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice best available treatment (BAT) in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation.

The study is expected to enroll approximately 116 patients at around 50 clinical sites in the United States and Europe. It is powered at 90% to show a statistically significant difference in the primary endpoint of overall survival (OS) from the time of study entry. Secondary endpoints to be measured include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The study will have a planned interim analysis for safety and futility after 80 events.

This streamlined CR2 study design, as compared to the previously planned study in AML patients who achieved complete remission following first-line antileukemic therapy (CR1), substantially reduces the study size (116 patients in CR2 vs. 390 patients in CR1) and time until topline data (up to 2.5 years in CR2 vs. 4.5 years in CR1) which will result in corresponding significant cost savings. A Phase 2a study of GPS in the AML CR2 setting conducted at the Moffitt Cancer Center previously demonstrated a clinically meaningful and statistically significant three-fold OS prolongation in patients receiving GPS when compared to a comparable group of contemporaneously assessed unvaccinated patients with a median OS of 16.3 months vs 5.4 months and a p-value of 0.0175, respectively, with treatment-related adverse events primarily comprised of grade 1 or 2 local injection site reactions and only one grade 3 (transient leukopenia) adverse event. A prior Phase 2 study of GPS in AML patients who achieved CR1 also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

"We are excited to begin this late-stage Phase 3 program with GPS in AML. Earlier studies have positioned this agent to be a potentially effective approach in prolonging survival by delaying or preventing recurrence in patients in complete remission, most of whom harbor measurable residual disease and have a poor prognosis if they are unable to undergo allotransplant. We are hopeful that this new immunotherapeutic vaccine approach will improve outcomes in this patient population, which is at a very high risk of leukemic relapse," said Hagop M. Kantarjian, MD, Professor and Chair of the Department of Leukemia at the University of Texas MD Anderson Cancer Center, and principal investigator of the upcoming Phase 3 AML clinical development program.

On November 28, 2018 Geron Corporation (Nasdaq: GERN) reported that the Company’s analyst and investor event will take place in New York, N.Y., on Monday, December 10, 2018 (Press release, Geron, NOV 28, 2018, View Source [SID1234531717]). Management will be joined by clinical investigators from both IMerge and IMbark who will reprise oral presentations from the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting occurring in early December, as well as discuss the unmet medical need in hematologic myeloid malignancies. The event will begin at 8:00 a.m. ET.

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Azra Raza, M.D., Chan Soon-Shiong Professor of Medicine and Director of the MDS Center in New York, will review data from Part 1 of the ongoing Phase 2/3 IMerge clinical trial of the telomerase inhibitor imetelstat in patients with lower risk myelodysplastic syndromes, including more mature efficacy and safety data from the combined initial and expansion cohorts presented at ASH (Free ASH Whitepaper).

John Mascarenhas, M.D., Associate Professor of Medicine in the Myeloproliferative Disorders Program of the Tisch Cancer Institute, Division of Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, will review data from IMbark, the ongoing Phase 2 clinical trial of imetelstat in patients with Intermediate-2 or High-risk myelofibrosis, including more mature data from the extension phase of IMbark presented at ASH (Free ASH Whitepaper), including median overall survival.

Analysts and investors in attendance will be able to ask questions of the investigators during the question and answer session following the presentations. In addition, the Company will also discuss its development plans for imetelstat, including the start of the Phase 3 portion of IMerge by mid-year 2019.

A live audio webcast of the event will be available on Geron’s website, www.geron.com/investors/events. If you are unable to listen to the live event, an archived webcast of the event will be available on the Company’s website for 30 days