Pfizer Inc. announced today that PROFILE 1014, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor XALKORI® (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) when compared to standard platinum-based chemotherapy regimens. PROFILE 1014 is the second positive global Phase 3 study that evaluated XALKORI against chemotherapy, a standard of care for patients with advanced NSCLC.
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Press Release Archive
Pfizer Inc. (NYSE:PFE) announced today detailed results from OPT Compare (A3921080), a Phase 3 study of tofacitinib, the first in a new class of treatment, oral Janus kinase (JAK) inhibitors, the safety and efficacy of which are being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10 – 25 years of age.
Pfizer Inc. (NYSE:PFE) today announced the launch of its fourth integrated annual review (www.pfizer.com/annual), which summarizes the company’s 2013 financial, environmental and social responsibility performance.
Pfizer Inc. confirmed today that the United States District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (U.S. Patent No. RE44,048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®.
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by Pfizer’s Oncology leadership on Sunday, April 6, 2014 at 1:30 p.m. Pacific Daylight Time, in connection with the presentation of the final results of the PALOMA-1 Phase 2 trial for palbociclib at the American Association for Cancer Research (AACR) Annual Meeting 2014. There will be a Q&A session following the presentation during the webcast.
Pfizer Inc. (NYSE:PFE) today presented detailed results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. Results were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.
Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the current label of XELJANZ® (tofacitinib citrate) 5 mg tablets to include radiographic data from two Phase 3 studies, ORAL Scan (A3921044) and ORAL Start (A3921069). “XELJANZ is the first oral JAK inhibitor for moderately to severely active rheumatoid arthritis. The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinically meaningful outcome for patients,” said Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business.
Pfizer Inc. (NYSE: PFE) today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of age and older, achieved its primary clinical objective and both secondary clinical objectives. CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.
Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. ARISTOTLE was designed to evaluate the efficacy and safety of Eliquis compared to warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). This subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and reducing the risk of all-cause death with fewer bleeding events. Owing to the higher risk at older age (age 75 and older), the absolute benefit to patients with NVAF was greater with Eliquis in the older population. These data were published today in the European Heart Journal.
Pfizer agrees with the recommendation of the joint meeting of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee that the available data do not support a conclusion that naproxen has a lower risk of cardiovascular thrombotic events as compared to other non-steroidal anti-inflammatory drugs (NSAIDs).
Pfizer Inc. (NYSE:PFE) announced today that it has agreed with Merck & Co., Inc., known as MSD outside the United States and Canada (“Merck”), through two Merck subsidiaries, to explore the therapeutic potential of Merck’s investigational anti-PD-1 therapy, MK-3475, in combination with two Pfizer oncology assets. A Phase I/II clinical study will evaluate the safety and anti-cancer efficacy of MK-3475 combined with Pfizer’s axitinib (INLYTA®) in renal cell carcinoma (RCC). A separate Phase I study will evaluate the safety and tolerability of the combination of MK-3475 and PF-05082566 (PF-2566), Pfizer’s investigational, fully humanized monoclonal antibody (mAb) that stimulates signaling through 4-1BB (CD-137), a protein involved in regulation of immune cell proliferation and survival.
Pfizer Inc. (NYSE: PFE) today announced that the randomized Phase 2 trial [PALOMA-1] of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib and letrozole compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed metastatic breast cancer.
Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2013. As a result of the full disposition of Zoetis(3) on June 24, 2013, the financial results of the Animal Health business are reported as a discontinued operation in the consolidated statements of income for full-year 2013, and fourth-quarter and full-year 2012. Results and guidance are summarized below.
Pfizer Inc. (NYSE:PFE) today announced top-line results from two randomized Phase 3 studies of the irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced non-small cell lung cancer (NSCLC).
Pfizer Inc. (NYSE: PFE) announced today top-line results from a Phase 3 study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic low back pain. In this study, ALO-02 met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo.
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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