On November 4, 2016 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that data from three drug candidates in its development pipeline will be presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Expo (Press release, GlycoMimetics, NOV 4, 2016, View Source [SID1234516348]). The ASH (Free ASH Whitepaper) meeting will take place December 3 to 6, 2016, at the San Diego Convention Center.

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The oral presentation and six posters to be shared at the ASH (Free ASH Whitepaper) meeting will review the results of pre-clinical and clinical research on the pan-selectin antagonist, rivipansel, that GlycoMimetics is developing in partnership with Pfizer, Inc.; the company’s E-selectin antagonist, GMI-1271; and the company’s dual E-selectin/CXCR4 antagonist, GMI-1359. The data presented will show significant progress in a clinical trial for acute myeloid leukemia (AML), pre-clinical data further expanding on the mechanism and potential for therapeutic benefit in sickle cell anemia, and pre-clinical data on effects of GMI-1359 in models of hematologic malignancies. The company will present updates with interim data from an on-going Phase 1/2 trial of GMI-1271 in patients with AML. This will include an update on patients enrolled in the Phase 1 portion of the trial as well as data on evaluable patients enrolled to date in the two Phase 2 arms of the study. The Phase 2 portion includes one arm enrolling patients with relapsed or refractory disease and one arm enrolling patients over the age of 60 with newly diagnosed disease.

"We are delighted to have multiple abstracts accepted at ASH (Free ASH Whitepaper), highlighting the success and breadth of our growing pipeline," said Rachel King, Chief Executive Officer of GlycoMimetics. "Our new clinical and preclinical data show the scientific rationale for continuing development of all three drug candidates, as well as significant momentum in our clinical program for GMI-1271 in AML."

Details of the data to be presented at ASH (Free ASH Whitepaper), including session times and locations, include:

Oral Presentation (submitted by Pfizer, Inc.)

Abstract #270-Rivipansel: A Small Pan-Selecting Antagonist Improves Cerebral Perfusion and Inhibits Leukocyte Adhesion and in Murine Sickle Cell Disease Model. Sunday, Dec. 4, 7:30-9:00 a.m. PT, Room 7AB.

Posters (all poster sessions are in the San Diego Convention Center, Hall G)

Abstract #4049–A Phase I/II Study of GMI¬1271, a Novel E¬Selectin Antagonist, in Combination with Induction Chemotherapy in Relapsed/Refractory and Elderly Previously Untreated Acute Myeloid Leukemia; Results to Date. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session

Abstract #3826–E¬Selectin Antagonist GMI¬1271 Shows a Favorable Safety, PK and Bleeding Profile in Phase I Studies of Healthy Volunteers. Monday, Dec. 5, 6:00-8:00 p.m. PT. Poster Session

Abstract #2823–Vascular E-Selectin Protects Leukemia Cells from Chemotherapy By Directly Activating Pro-Survival NF-Kb Signaling – Therapeutic Blockade of E-Selectin Dampens NF-Kb Activation. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #3519—Dual E-Selectin/CXCR4 Antagonist GMI-1359 Exerts Efficient Anti-Leukemia Effects in a FLT3 ITD Mutated Acute Myeloid Leukemia Patient-Derived Xenograph Murine Model. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #2826—Administration of the Dual E-Selectin/CXCR4 Antagonist, GMI-1359, Results in a Unique Profile of Tumor Mobilization from the Bone Marrow and Facilitation of Chemotherapy in a Murine Model of FLT3 ITD AML. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

Abstract #2509–Rivipansel (GMI-1070) Inhibits E-Selectin Recognition of Sialyl LewisX Activation and Arrest of Human Neutrophils Expressed on CD62L (L-selectin) and Blocks Integrin. Sunday Dec. 4, 6:00-8:00 p.m. PT. Poster Session

The meeting abstracts are available at ASH (Free ASH Whitepaper)’s website.

On November 4, 2016 Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) reported a business update and reported financial results for the third quarter ended September 30, 2016 (Filing, Q3, Anthera, 2016, NOV 4, 2016, View Source [SID1234516255]).

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Recent Developments and Business Highlights:

Blisibimod for the treatment of Systemic Lupus Erythematosus ("SLE")

o Topline Data from Phase 3 CHABLIS-SC1 Clinical Study
We have been working diligently through the adjudication for the CHABLIS-SC-1 study, which completed the last patient visit in September. We currently plan to report topline efficacy and safety data prior to the 2016 American College of Rheumatology Annual Meeting taking place from November 11th to November 16th. Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study. For more information on the CHABLIS-SC1 study, please visit View Source

o Phase 3 CHABLIS 7.5 Clinical Study Enrollment and Clinical Site Activation On Track
We continued further clinical site activation for, and enrollment in CHABLIS 7.5, our second Phase 3 clinical study. This study will evaluate the efficacy and safety of blisibimod in patients who, despite corticosteroid use, continue to have clinically-active lupus (SLE) and the presence of anti-double-stranded DNA and low complements which are known serological markers of lupus. For more information about the CHABLIS 7.5 study, visit View Source

Sollpura (liprotamase) for the treatment of Exocrine Pancreatic Insufficiency ("EPI")

o Phase 3 SOLUTION Clinical Study
Following the completion of patient enrollment in our Phase 3 SOLUTION study, an independent Data and Safety Monitoring Board (DSMB) recommended continuation of the study without modification on August 3, 2016. Subsequent assessment by the DSMB on September 25, 2016, found no concerning safety signals. We expect to report topline efficacy data from the SOLUTION study before the end of 2016. For more information on the SOLUTION clinical study, please visit View Source

o SIMPLICITY Clinical Study Enrollment on Track
Enrollment in the SIMPLICITY study, which intends to evaluate the efficacy and safety of Sollpura supplied as a powder for oral solution, is on track. In this study, Sollpura is delivered in a convenient, easy-to-administer single use package. We completed enrollment of the initial cohort of patients 7 years of age and above, and following a review of safety and efficacy data by an independent DSMB, the study will allow for administration of Sollpura powder for oral solution to pediatric patients ranging in age from 28 days to less than 7 years. For more information on the study, please visit View Source

o EASY Clinical Study
During the third quarter of 2016, we initiated the EASY study, which provides continued access to Sollpura for patients who completed the SOLUTION study. We plan to continue the EASY study until Biologic License Application ("BLA") for Sollpura is approved by the U.S. Food and Drug Administration ("FDA").

o Manufacturing to Support Commercial Readiness Accelerated
We began acceleration of the manufacturing scale-up to support the commercial launch of Sollpura including the completion of demonstration and registration batches at commercial launch scale. We had a Type-C meeting with the FDA in September to discuss the manufacturing approach for the Lipase-CLEC drug substance and the conversion of the filed Sollpura New Drug Application ("NDA") to a BLA. The FDA confirmed that Sollpura fits the regulatory definition of a biologic, supporting the conversion of the filed NDA to a BLA. Furthermore, preliminary agreement was reached on Anthera’s approach to demonstration of comparability of drug substance manufactured by a new contract manufacturing organization ("CMO"), and the potential use of a comparability protocol to manage post-approval process scale up.

Blisibimod for the treatment of IgA Nephropathy

o Longer-Term Evaluation Continues in Phase 2 BRIGHT-SC Clinical Study
In June 2016, an interim analysis of observed data from 57 patients, all of whom had the opportunity to complete 24 weeks of treatment, demonstrated a positive trend in lower proteinuria in blisibimod versus placebo treated patients over two years, supporting continuation of the study. Data from the 48-week evaluation is expected at the end of this year or in early first quarter of 2017. For more information about the BRIGHT-SC study, visit View Source

Management Update

· On August 16, 2016, we appointed William Shanahan, M.D., J.D. as Chief Medical Officer. In this role, Dr. Shanahan will oversee the clinical development of the blisibimod and Sollpura programs. Dr. Shanahan joins Anthera with over 30 years of drug development experience, including 16 years as a chief medical officer.

Summary of Financial Results

o Registered Direct Offering. In September 2016, we executed a subscription agreement with Biotechnology Value Fund, L.P. and other affiliates of BVF Partners L.P. ("BVF"), and Rock Springs Capital, pursuant to which we may sell convertible preferred stock in two tranches. The initial tranche closed on September 14 and we received gross proceeds of $17 million. The investors have an option for an additional $28.3 million of convertible preferred stock at their discretion. Each share of preferred stock is convertible into shares of common stock at various prices in the future. The initial $17 million of Series X convertible preferred stock received warrant coverage equal to 25% of the issued shares of common stock with an exercise price equal to 120% of the conversion price of the Series X convertible preferred stock.

o Cash Position. We ended the third quarter of 2016 with cash and cash equivalents totaling $32.6 million, compared to $47 million as of December 31, 2015. The decrease in cash was mainly attributable to $36.7 million used to fund our clinical development programs during the nine months ended September 30, 2016, offset by approximately $23 million in net proceeds received from the sale of common and preferred stock.

o R&D Expense. Research and development expenses for the three and nine months ended September 30, 2016 totaled $14.1 million and $35.7 million, respectively, compared to $10.4 million and $24.9 million for the corresponding periods in 2015. The increase is primarily due to cost associated with acceleration of the manufacturing scale-up timeline, including the production of demonstration and registration batches at commercial launch scale for Sollpura and the purchase and installation of manufacturing equipment at our contract manufacturers. Additionally, clinical development expense increased from prior year due to the initiation of three new clinical studies, namely the CHABLIS-7.5 study with blisibimod in severe lupus patients, the SIMPLICITY study with Sollpura in sachet formulation and the EASY study which provides continued access to Sollpura for patients who completed the SOLUTION study.

o G&A Expense. General and administrative expenses for the three and nine months ended September 30, 2016 totaled $2.5 million and $7.3 million, respectively, compared to $2.1 million and $5.7 million for the corresponding periods in 2015. The increase is primarily due to higher non-cash stock-based compensation expense recognized during the three and nine months ended September 30, 2016.

o Net Loss. Net loss for the three and nine months ended September 30, 2016 was $16.5 million and $42.5 million, respectively, compared to $11.3 million and $27.9 million for the corresponding periods in 2015. The increase in net loss is mainly attributable to the increase in manufacturing expense for Sollpura and clinical study expense for both Sollpura and blisibimod in 2016.

o Net Loss Applicable to Common Stockholders. In connection with the September 2016 registered direct offering of convertible preferred stock, warrants and option to purchase future shares of convertible preferred stock, there is an in-the-money conversion feature (beneficial conversion feature, or BCF) that required separate financial statement recognition and was recorded as a discount to the preferred shares and was immediately accreted as a deemed dividend because the shares are immediately convertible. For the quarter and nine months ended September 30, 2016, we recorded a deemed dividend of $8.8 million.

On November 4, 2016 Cancer Research UK and Cancer Research Technology (CRT), the charity’s commercial arm, reported an agreement with TYG oncology Ltd (TYG) to take its new antigen-specific, active checkpoint control cancer vaccine TYG100, into clinical trials in cancer patients with advanced solid tumours (Press release, Cancer Research Technology, APR 4, 2016, View Source [SID1234523176]).

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TYG100 is among a range of new treatments that use a patient’s own immune system to target hormones that encourage the growth and spread of solid tumours. It works by triggering the production of antibodies that specifically target two members of the gastrin hormone family* that help to fuel tumour growth.

Under the agreement, Cancer Research UK and TYG will share the cost of the process development and production of TYG100 for the clinic.

Cancer Research UK’s Centre for Drug Development (CDD) will then sponsor and manage a Phase I clinical trial of TYG100 in cancer patients with advanced solid tumours, mainly to evaluate drug safety and toxicity. It will take place across the Experimental Cancer Medicine Centres (ECMC) network, a nationwide initiative funded by Cancer Research UK and the UK’s four Health Departments.

The collaboration forms part of Cancer Research UK’s Clinical Development Partnership (CPD) scheme, meaning that at the end of the trial, TYG oncology has the option of either retaining rights to the new treatment or transferring them to Cancer Research UK to continue development through a new partner.

Fred Jacobs, president of TYG oncology, said: "We are very pleased to be working in partnership with the clinical experience and expertise from Cancer Research UK to advance TYG100. Cancer Research UK’s sponsorship of the Phase I clinical trial is a significant technical and financial validation of our novel therapeutic vaccine. TYG100 will be attacking some of the most difficult and deadliest solid tumours, including pancreatic and gastro-oesophageal cancers."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said: "We hope that next generation cancer vaccines like this one will build on the widespread success of existing hormonal treatments – such as those targeting oestrogen in breast cancer and testosterone in prostate cancer. It’s a very promising area of research and we’re excited to be working with TYG oncology to take this to the next stage."

"Our Clinical Development Partnerships are a novel approach that allows companies to benefit from Cancer Research UK’s extensive drug development resources in a way that is mutually beneficial and that ultimately helps new treatments reach patients more quickly."

On November 4, 2016 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company, reported preclinical findings and data from the company’s ongoing Phase 2 trial in HRAS mutant solid tumors at the 9th European Scientific Oncology Conference (ESOC-9) in Marbella, Spain. Antonio Gualberto, M.D., Ph.D., chief medical officer, delivered a presentation titled, "Targeting the RAS-ERK Pathway (Press release, Kura Oncology, NOV 4, 2016, View Source;p=RssLanding&cat=news&id=2219741 [SID1234516287])."

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Kura is currently evaluating tipifarnib, a farnesyl transferase inhibitor, as a potential treatment for patients with HRAS mutant solid tumors. In his presentation, Dr. Gualberto provided details on three patients with HRAS mutant squamous head and neck cancer (SCCHN), treated with tipifarnib. Two of the three SCCHN patients experienced a confirmed partial response (PR) and have been on study for 15 months and 8 months, while a third patient experienced disease stabilization for 7 months. The two partial responses were observed after 6 and 2 cycles of treatment, respectively. All three SCCHN patients had received prior treatment with cetuximab alone or in combination with chemotherapy but appeared to derive lesser benefit with those regiments than with the subsequent tipifarnib treatment.

"Despite the fact that HRAS was identified as an oncogene more than 40 years ago, there have been no effective therapeutic approaches in the clinic," said Dr. Gualberto. "These data may constitute the first demonstration of mechanism-based inhibition of HRAS in cancer patients, and support further investigation of tipifarnib in squamous head and neck cancer, an indication of high unmet need."

Dr. Gualberto’s slide presentation is available in the Scientific Presentations and Papers section of Kura Oncology’s website at www.kuraoncology.com.

On November 3, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported that data from 25 abstracts evaluating an important variety of investigational uses of the company’s portfolio of blood cancer medicines will be presented during the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 3-6, in San Diego, CA (Press release, AbbVie, NOV 3, 2016, View Source [SID1234516204]).

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AbbVie will present results from several studies evaluating ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK) being developed by Pharmacyclics, an AbbVie company, and Janssen Biotech, Inc., across a number of blood cancers. AbbVie will also present data on venetoclax, a BCL-2 inhibitor, being developed by AbbVie and Genentech, a member of the Roche Group. The scientific presentations describe the potential of ibrutinib and venetoclax in multiple hematologic malignancies, including chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML), among others. Data for elotuzumab, co-developed by Bristol-Myers Squibb and AbbVie, in MM will also be presented at the meeting.

"Every year the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting marks the opportunity to show AbbVie’s success in advancing important treatments for people impacted by cancer," said Dr. Gary Gordon, vice president, oncology development, AbbVie. "Through our work with scientists, doctors and patients, AbbVie is presenting data highlighting progress in the discovery and development of new and promising therapies to treat blood cancers."

AbbVie abstracts:

Ibrutinib

Outcomes of Ibrutinib Therapy by Age in Patients with CLL/SLL: Analyses from Phase 3 Trial Data (RESONATE and RESONATE-2); J.Woyach et al.; Abstract 2041; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
11q Deletion (del11q) Is Not a Prognostic Factor for Adverse Outcomes for Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Treated with Ibrutinib: Pooled Data from 3 Randomized Phase 3 Studies; T. Kipps et al.; Abstract 2042; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
Five-Year Experience with Single-Agent Ibrutinib in Patients with Previously Untreated and Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia; S. O’Brien et al.; Abstract 233; Oral Session; Saturday, December 3, 2016; 5 p.m. PST
Updated Efficacy and Safety from the Phase 3 RESONATE-2 Study: Ibrutinib as First-Line Treatment Option in Patients 65 Years and Older with Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia; P. Barr et al.; Abstract 234; Oral Session; Saturday, December 3, 2016; 5:15 p.m. PST
Single-Agent Ibrutinib Demonstrates Efficacy and Safety in Patients with Relapsed/Refractory Marginal Zone Lymphoma: A Multicenter, Open-Label, Phase 2 Study; A. Noy et al.; Abstract 1213; Oral Session; Monday, December 5, 2016; 6:15 p.m. PST
A Multicenter Open-Label Phase 1b/2 Study of Ibrutinib in Combination with Lenalidomide and Rituximab in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL); A. Goy et al.; Abstract 473; Oral Session; Sunday, December 4, 2016; 5:30 p.m. PST
Ibrutinib Combined with Rituximab in Treatment-Naïve Patients with Follicular Lymphoma: Arm 1 + Arm 2 Results from a Multicenter, Open-Label Phase 2 Study; N. Fowler et al.; Abstract 1804; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
Integrated and Long-Term Safety Analysis of Ibrutinib in Patients with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL); S. Coutre et al.; Abstract 4383; Poster Session; Monday, December 5, 2016; 6-8 p.m. PST
Changes in Clinical Stage Identify Different Response Categories among Patients in iwCLL PR: Analysis of CLL Patients on the RESONATE Study; C. Moreno et al.; Abstract 4384; Poster Session; Monday, December 5, 2016; 6-8 p.m. PST
Ibrutinib Potentiated NK Cell-Mediated Cytotoxicity in Mouse Models of B-Cell Lymphomas; H. Kuo et al.; Abstract 4140; Poster Session; Monday, December 5, 2016; 6-8 p.m. PST

Venetoclax

M13-365: Detailed Safety Analysis of Venetoclax Combined with Rituximab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia; D. Brander et al.; Abstract 2033; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
M14-032: Venetoclax (VEN) Monotherapy for Patients with Chronic Lymphocytic Leukemia (CLL) Who Relapsed After or Were Refractory to Ibrutinib or Idelalisib; J. Jones et al.; Abstract 637; Oral Session; Monday, December 5, 2016; 7 a.m. PST
Safety Profile of Venetoclax Monotherapy in Patients with Chronic Lymphocytic Leukemia; J. Seymour et al.; Abstract 4395; Poster Session; Monday, December 5, 2016; 6-8 p.m. PST
Attainment of Complete Remission is Significantly Associated with Longer Survival Outcomes in Relapsed/Refractory (R/R) CLL: A Meta-Analysis; V. Ektare et al.; Abstract 2045; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
Pooled Multi-trial Analysis of Venetoclax Efficacy in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia; A. Roberts et al.; Abstract 3230; Poster Session; Sunday, December 4, 2016; 6-8 p.m. PST
M13-367: Venetoclax Monotherapy for Relapsed/Refractory Multiple Myeloma: Safety and Efficacy Results from a Phase I Study; S. Kumar et al.; Abstract 488; Oral Session; Sunday, December 4, 2016; 4:30-6 p.m. PST
M12-901: Venetoclax Combined with Bortezomib and Dexamethasone for Patients with Relapsed/Refractory Multiple Myeloma; P. Moreau et al.; Abstract 975; Oral Session; Monday, December 5, 2016; 2:45-4:15 p.m. PST
Correlative Biomarkers of Response to Venetoclax in Combination with Chemotherapy or Hypomethylating Agents in Elderly Untreated Patients with Acute Myeloid Leukemia; B. Chyla et al.; Abstract 1709; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
M14-387: Safety and Efficacy of Venetoclax Plus Low-Dose Cytarabine in Treatment-Naïve Patients Aged >=65 Years with Acute Myeloid Leukemia (AML); A. Wei et al.; Abstract 102; Oral Session; Saturday, December 3, 2016; 9:30-11 a.m. PST
BO29337 (CONTRALTO): Phase 2 Study of Venetoclax plus Rituximab or Bendamustine+Rituximab Versus BR Alone in Relapsed/Refractory Follicular Lymphoma: Preliminary Data; Hiddemann et al.; Oral Session; Monday, December 5, 2016; 7-8:30 p.m. PST
GO28440: Results of a Phase Ib Study (GO28440) of Venetoclax with Bendamustine/Rituximab or Bendamustine/Obinutuzumab in Patients with Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia; Salles et al.; Poster Session; Monday, December 5, 2016; 6-8 p.m. PST
GO27878 (CAVALLI): Results of a Phase Ib Study of Venetoclax Plus R- or G-CHOP in Patients with B-cell Non-Hodgkin Lymphoma; A. Zelenetz et al.; Poster Session; Sunday, December 4, 2016; 6-8 p.m. PST
BCL-2 Family Expression Favor t(11;14)+ Patients Amongst Molecular Subgroups of Multiple Myeloma, for Susceptibility to Single Agent Venetoclax; J. Wu et al.; Online Publication

Elotuzumab

Safety and Efficacy of Elotuzumab with Lenalidomide/Dexamethasone for Multiple Myeloma in a Japanese Subpopulation Analysis of the Phase 3 ELOQUENT-2 Trial; K. Ohashi et al.; Abstract 3315; Poster Session; Sunday, December 4, 2016; 6-8 p.m. PST
Budget Impact Analysis of Introducing Elotuzumab in Combination with Lenalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A U.S. Payer Perspective; R. Potluri et al.; Abstract 2363; Poster Session; Saturday, December 3, 2016; 5:30-7:30 p.m. PST
The ASH (Free ASH Whitepaper) 2016 Annual Meeting abstracts are available at View Source

About IMBRUVICA (ibrutinib) in the U.S.
IMBRUVICA is a first-in-class, oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells.1,2 IMBRUVICA blocks signals that tell malignant B cells to multiply and spread uncontrollably.1

IMBRUVICA is approved to treat patients with CLL/SLL, patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and patients with Waldenström’s macroglobulinemia. Accelerated approval was granted for the MCL indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.1

IMBRUVICA was one of the first medicines to receive U.S. FDA approval via the new Breakthrough Therapy Designation pathway.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers. More than 6,000 patients have been treated with IMBRUVICA in clinical trials. Currently, 14 Phase 3 trials have been initiated with IMBRUVICA and more than 90 trials are registered on www.clinicaltrials.gov.

Patient Access to IMBRUVICA
AbbVie and Janssen strive to make access to IMBRUVICA easy by helping patients understand their insurance benefits for IMBRUVICA. The YOU&i Support Program is a personalized program that includes information on access and affordability, nurse call support and resources for patients being treated with IMBRUVICA. This includes the YOU&i Instant Savings program, which provides co-pay support to eligible commercially insured IMBRUVICA patients. Patients can access the program by contacting 1-877-877-3536, option 1 or by visiting View Source

The YOU&i Instant Savings program is not available for patients enrolled in Medicare or Medicaid. For a list of patient support organizations that may be able to provide financial support please visit: View Source

U.S. IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage – Fatal bleeding events have occurred in patients treated with IMBRUVICA. Grade 3 or higher bleeding events (intracranial hemorrhage [including subdural hematoma], gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA.

The mechanism for the bleeding events is not well understood. IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and patients should be monitored for signs of bleeding. Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre- and postsurgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and nonfatal infections have occurred with IMBRUVICA therapy. Grade 3 or greater infections occurred in 14% to 29% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA. Evaluate patients for fever and infections and treat appropriately.

Cytopenias – Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19% to 29%), thrombocytopenia (range, 5% to 17%), and anemia (range, 0% to 9%) based on laboratory measurements occurred in patients treated with single agent IMBRUVICA. Monitor complete blood counts monthly.

Atrial Fibrillation – Atrial fibrillation and atrial flutter (range, 6% to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, hypertension, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. Atrial fibrillation should be managed appropriately and if it persists, consider the risks and benefits of IMBRUVICA treatment and follow dose modification guidelines.

Hypertension – Hypertension (range, 6% to 17%) has occurred in patients treated with IMBRUVICA with a median time to onset of 4.6 months (range, 0.03 to 22 months). Monitor patients for new-onset hypertension or hypertension that is not adequately controlled after starting IMBRUVICA. Adjust existing antihypertensive medications and/or initiate antihypertensive treatment as appropriate.

Second Primary Malignancies – Other malignancies (range, 5% to 16%) including non-skin carcinomas (range, 1% to 4%) have occurred in patients treated with IMBRUVICA. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4% to 13%).

Tumor Lysis Syndrome – Tumor lysis syndrome has been infrequently reported with IMBRUVICA therapy. Assess the baseline risk (e.g., high tumor burden) and take appropriate precautions. Monitor patients closely and treat as appropriate.

Embryo-Fetal Toxicity – Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA and for 1 month after cessation of therapy. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (?20%) in patients with B-cell malignancies (MCL, CLL/SLL, and WM) were neutropenia* (64%), thrombocytopenia* (63%), diarrhea (43%), anemia* (41%), musculoskeletal pain (30%), rash (29%), nausea (29%), bruising (29%), fatigue (27%), hemorrhage (21%), and pyrexia (21%).

*Based on adverse reactions and/or laboratory measurements (noted as platelets, neutrophils, or hemoglobin decreased).

The most common Grade 3 or 4 non-hematologic adverse reactions (?5%) in MCL patients were pneumonia (7%), abdominal pain (5%), atrial fibrillation (5%), diarrhea (5%), fatigue (5%), and skin infections (5%).

Approximately 6% (CLL), 14% (MCL), and 11% (WM) of patients had a dose reduction due to adverse reactions.

Approximately 4%-10% (CLL), 9% (MCL), and 6% (WM) of patients discontinued due to adverse reactions. Most frequent adverse reactions leading to discontinuation were pneumonia, hemorrhage, atrial fibrillation, rash and neutropenia (1% each) in CLL patients and subdural hematoma (1.8%) in MCL patients.

DRUG INTERACTIONS

CYP3A Inhibitors – Avoid coadministration with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

CYP3A Inducers – Avoid coadministration with strong CYP3A inducers.

SPECIFIC POPULATIONS

Hepatic Impairment – Avoid use in patients with moderate or severe baseline hepatic impairment. In patients with mild impairment, reduce IMBRUVICA dose.

Please see full U.S. Prescribing Information: View Source

About Venclexta (venetoclax) in the U.S.
Venclexta (venetoclax) is an oral B-cell lymphoma-2 (BCL-2) inhibitor indicated in the U.S. for the treatment of patients with relapsed/refractory CLL with 17p deletion, as detected by an FDA-approved test.3 The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.3 Venclexta is designed to selectively inhibit the BCL-2 protein.3 Venclexta was developed in collaboration with Genentech and Roche.

Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory and first-line CLL, along with early phase studies in several cancers.

Venetoclax is under evaluation by health authorities in multiple countries, and is currently approved in Argentina, Puerto Rico and Canada.