On Friday, Pfizer Inc. (NYSE:PFE)’s shares declined -0.94% to $32.07.
Pfizer Inc. (PFE) declared that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted Preceding Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE® (palbociclib). If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant as compared to fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, counting those with and without preceding treatment for their metastatic disease. The Prescription Drug User Fee Act (PDUFA) aim date for a decision by the FDA is April 2016.
If Pfizer’s sNDA is approved, the updated IBRANCE label would comprise results from two metastatic breast cancer trials in which IBRANCE in combination with an endocrine therapy improved progression-free survival (PFS) contrast to endocrine therapy alone, PALOMA-1 and PALOMA-3.
Based on the results of the PALOMA-1 trial, IBRANCE was approved by the FDA in February 2015 for use in combination with letrozole as a treatment for postmenopausal women with estrogen receptor-positive (ER+), HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.1 This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing confirmatory trial, PALOMA-2. The most frequently stated adverse event for IBRANCE plus letrozole in PALOMA-1 was neutropenia. For more information on the serious and most common side effects of IBRANCE plus letrozole, please see Important IBRANCE Safety Information at the end of this release.
Pfizer Inc., a biopharmaceutical company, discovers, develops, manufactures, and sells healthcare products worldwide. The company operates through Global Innovative Pharmaceutical (GIP); Global Vaccines, Oncology and Consumer Healthcare (VOC); and Global Established Pharmaceutical (GEP) segments.
Merck & Co., Inc. (NYSE:MRK)’s shares dropped -2.03% to $52.15.
Eli Lilly and Company (LLY) and Merck (MRK), known as MSD outside the United States and Canada, recently declared another immuno-oncology partnership that will evaluate abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, and Merck’s KEYTRUDA® (pembrolizumab) in a Phase I study across multiple tumor types. Based on the Phase I trial results, the partnershiphas the potential to progress to Phase II trials in patients who have been diagnosed with either metastatic breast cancer or non-small cell lung cancer (NSCLC).
Lilly is the sponsor of the Phase I study, and of any subsequent Phase II studies, per the terms of the agreement. Enrollment is planned to start in early 2016. Financial details of the partnership were not revealed.
Lilly’s abemaciclib is a cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting CDK4 and CDK6. Pembrolizumab is a humanized monoclonal antibody that operates by increasing the ability of the body’s immune system to assist detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
“With our active Phase III program underway for abemaciclib in both metastatic breast cancer and non-small cell lung cancer, we are committed to uncovering every opportunity to assist these patients – and this comprises exploring abemaciclib in combination with immunotherapy,” said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. “We’re encouraged by our productive immuno-oncology collaborations with Merck, through its associates, and coming together for another clinical trial is a natural evolution of our scientific collaboration.”
Merck & Co., Inc. provides health care solutions worldwide. The company offer therapeutic and preventive agents to treat cardiovascular, type 2 diabetes, asthma, nasal allergy symptoms, allergic rhinitis, chronic hepatitis C virus, HIV-1 infection, fungal infections, intra-abdominal infections, hypertension, arthritis and pain, inflammatory, osteoporosis, male pattern hair loss, and fertility diseases.
At the end of Friday’s trade, FMC Corp (NYSE:FMC)‘s shares dipped -3.77% to $37.99.
FMC Corporation (FMC) declared that its Board of Directors declared a regular quarterly dividend of 16.5 cents per share, payable on January 21, 2016, to shareholders of record at the close of business on December 31, 2015.
FMC Corporation, a diversified chemical company, provides solutions, applications, and products for the agricultural, consumer, and industrial markets in North America, Europe, the Middle East, Africa, Latin America, and the Asia Pacific. The company operates through three segments: FMC Agricultural Solutions, FMC Health and Nutrition, and FMC Lithium.