Pfizer today announced overall survival (OS) results from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE® (palbociclib) in combination with fulvestrant compared to placebo plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed after prior endocrine therapy. The results demonstrated a positive trend in the hazard ratio favoring the IBRANCE combination, although this trend did not reach statistical significance. Overall survival is a secondary endpoint of the PALOMA-3 trial and, as such, the trial design was not optimized to detect a statistically significant difference in OS.
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Press Release Archive
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, July 31, 2018. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2018 Performance Report, to be issued that morning.
Pfizer Inc. announced today it will extend its donation of the antibiotic Zithromax® (azithromycin) to the International Trachoma Initiative through 2025, building on the company’s 20-years of work to help eliminate the world’s leading infectious cause of blindness. Approximately 163 million people are at risk of developing the disease and this recommitment ensures that Pfizer, through the International Trachoma Initiative (ITI), will continue to provide trachoma endemic countries with donated antibiotics that are a critical component of the global strategy to eliminate this neglected tropical disease (NTD).
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company’s New Drug Application for talazoparib. The submission is based on results from the EMBRACA trial, which evaluated talazoparib versus chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC). Talazoparib is an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.
Pfizer Inc. (NYSE:PFE) today announced it plans to invest $600 million in biotechnology and other emerging growth companies through Pfizer Ventures, the company’s venture investment vehicle. In addition to increased funding, Pfizer will extend its leadership as a venture capital investor with an expanded team that leverages expertise across venture capital investing, business development, drug discovery and clinical development.
Pfizer Inc. (NYSE:PFE) today announced overall survival (OS) data from the ARCHER 1050 trial evaluating dacomitinib as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations compared to gefitinib. The trial showed a median OS of 34.1 months for patients receiving dacomitinib (95% CI: 29.5, 37.7), representing a more than seven-month improvement compared to 26.8 months with gefitinib (95% CI: 23.7, 32.1). The OS data from ARCHER 1050 were presented today as an oral presentation [Abstract #9004] at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago and have been published simultaneously in the Journal of Clinical Oncology.
Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that updated efficacy and safety data from the pivotal JAVELIN Merkel 200 trial of BAVENCIO® (avelumab) in patients with metastatic Merkel cell carcinoma . . .
Pfizer Inc. (NYSE:PFE) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for TRAZIMERA™, a potential biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.1
Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib) 10 mg twice-daily (BID) for at least eight weeks, followed by XELJANZ 5 mg BID or 10 mg BID, for the treatment of adult patients in the U.S. with moderately to severely active ulcerative colitis (UC).1
The Pfizer Foundation announced today a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for women and men at the same time children are routinely vaccinated. These new grants build on The Pfizer Foundation’s existing grant program by providing a second round of funding to international nongovernmental organizations (INGOs) in five African countries where different barriers exist for women to access family planning services, bringing the total program funding to $11.7 million to date.
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for XALKORI® (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.
Pfizer Inc. (NYSE:PFE) announced today that tafamidis received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for the treatment of patients with transthyretin cardiomyopathy, a rare, fatal, and underdiagnosed condition associated with progressive heart failure.1,2
Pfizer Inc. (NYSE: PFE) announced today that results from a study analyzing real-world effectiveness data found that Prevnar 13® (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) reduced the risk of hospitalization from vaccine-type pneumococcal community-acquired pneumonia (CAP) by 73% (95% CI: 12.8−91.5%) in adults aged 65 and older.1 Importantly, Prevnar 13 (PCV13) worked under real-world conditions where people received pneumococcal vaccination as advised by their health care providers, and many had underlying medical conditions that increase the risk for pneumococcal pneumonia.1 The results were published in Clinical Infectious Diseases .
Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1/2 trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adult volunteers. RSV is a common respiratory virus that affects the lungs and airways, with significant impact on young children and older adults. The highest risk of severe outcome from RSV occurs in the first months of life.3
Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, and Pfizer (NYSE:PFE), today announced that, with a cumulative follow-up of more than 18 patient years of observation (5 to 121 weeks), all 15 participants in the ongoing Phase 1/2 clinical trial of investigational SPK-9001 for severe or moderately severe (FIX:C < 2 percent) hemophilia B, had discontinued routine infusions of factor IX concentrates.
Pfizer Inc. (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age. Results showed that adjunctive treatment with LYRICA 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo, the primary efficacy endpoint. Treatment with LYRICA at the lower dose (7 mg/kg/day) did not result in a statistically significant reduction in seizure frequency versus placebo. The study was a post-marketing requirement by the U.S. Food and Drug Administration (FDA). LYRICA is not approved as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.
Pfizer Inc. today announced that new data from its diversified portfolio of marketed and investigational oncology medicines will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5, 2018. Data from programs in small molecules, immunotherapies, biomarker-driven medicines, as well as biosimilars, will be featured in more than 40 abstracts, including company-sponsored and collaborative research studies.
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S.
Pfizer reported financial results for first-quarter 2018 and reaffirmed all components of 2018 financial guidance.
The board of directors of Pfizer Inc. today declared a 34-cent second-quarter 2018 dividend on the company’s common stock, payable June 1, 2018, to shareholders of record at the close of business on May 11, 2018.
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.
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