The FDA has approved Pfizer’s Vizimpro [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Andy Schmeltz, global president, Pfizer Oncology commented, “With today’s approval, Pfizer has…
Pfizer’s Tafamidis Phase 3 Study Shows Reduced Risk of Transthyretin Cardiomyopathy Mortality
The primary results from Pfizer’s Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, which showed tafamidis significantly reduced the hierarchical combination of both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (P=0.0006) in patients with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM).1 ATTR-CM is a rare, fatal, and underdiagnosed condition…
Pfizer’s Talazoparib Granted Priority Review
Pfizer announced that the FDA 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,…
Pfizer Cardiomyopathy Drug Granted Breakthrough Therapy Designation
Pfizer Inc. announced that tafamidis received Breakthrough Therapy designation from the U.S. 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 This decision is supported by topline results from the tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, in which tafamidis…
Pfizer Provides Update On Phase 3 Trial Of Axitinib
Pfizer Inc. announced that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating Inlyta (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility. The recommendation was based on the study failing to demonstrate…
FDA And European Medicines Agency Accept Regulatory Submissions For Review Of Dacomitinib
Pfizer Inc. announced that the FDA accepted the company’s New Drug Application and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations. The European Agency has also accepted the Marketing…
Pfizer Receives FDA Breakthrough Therapy Designation for Oral Jak1 Inhibitor to Treat Atopic Dermatitis
Pfizer Biosimilar To Rituxan Demonstrates Positive Results In Study
Pfizer Inc. announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan (rituximab-U.S.)/MabThera1. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with CD20-positive, low tumor burden, follicular lymphoma.…
Pfizer Establishes New Partnering Model For Early-Stage Academic Research
Pfizer Inc. announced the creation of the Innovative Target Exploration Network (ITEN), a new, early-stage partnering model that enables collaborative relationships with select academic institutions and principal investigators around the world, to identify research projects that have the potential to deliver novel therapeutic targets and mechanisms of action to underpin future drug discovery in core areas…
FDA OKs Pfizer’s Bosulif For Treatment Of Chronic Myelogenous Leukemia
U.S. FDA approves Pfizer’s Bosulif (bosutinib) for the treatment of patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML). The U.S. Food and Drug Administration (FDA) approved Pfizer Inc.”s supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA…
FDA Approves Pfizer’s Xeljanz For Psoriatic Arthritis Treatment
Pfizer announces FDA approval of Xeljanz (tofacitinib) and Xeljanz XR for the treatment of active psoriatic arthritis. The Food and Drug Administration (FDA) has approved Xeljanz 5 mg twice daily (BID) and Xeljanz XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis who have had an…
FDA Approves New Pfizer Biosimilar
The Food and Drug Administration (FDA) has approved Pfizer’s Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade (infliximab)* for all eligible indications of the reference product.1 The FDA has approved Ixifi as a treatment for patients with rheumatoid arthritis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis,…
Clinical Trial Reinforces Benefit Of Pfizer’s Ibrance In Breast Cancer Treatment
Updated data from Phase 3 trial of Ibrance (palbociclib) plus letrozole in ER+, HER2- metastatic breast cancer confirm improvement in progression-free survival. Pfizer Inc. today announced updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial reinforcing the clinical benefit of Ibrance (palbociclib) combined with letrozole. The data, which will be presented at the 2017 San…
Pfizer’s Drug Approved As Adjuvant Treatment In Recurrent Renal Cell Carcinoma
Pfizer receives FDA approval for Sutent (sunitinib malate) as first and only adjuvant treatment for adult patients at high risk of recurrent renal cell carcinoma. The U.S. Food and Drug Administration has approved a new indication expanding the use of Pfizer Inc.’s Sutent (sunitinib malate) to include the adjuvant treatment of adult patients at high…
Pfizer Gets Application Nod from FDA & EMA on RCC Treatment
Pfizer’s Trumenba Receives EC Approval to Fight Meningococcal Disease
European Commission approves Pfizer’s Trumenba to help prevent meningococcal group B disease in adolescents and adults. Meningococcal group B (MenB) is responsible for 60 percent of meningococcal disease cases in adolescents and young adults in Europe1 Pfizer Inc. announced today that the European Commission (EC) has approved Trumenba (meningococcal group B vaccine) for the prevention of invasive…
FDA Advisory Committee Recommends Approval of Pfizer’s Epogen/Procrit biosimilar
Pfizer Inhibitor Gets Breakthrough Designation for Lung Cancer
Pfizer Launches New Antibiotic in Europe
Pfizer launches Zavicefta (ceftazidime-avibactam) in the U.K. and Germany, a new antibiotic to treat complicated infections caused by Gram-negative bacteria. Pfizer Inc. announced that Zavicefta, a novel combination antibiotic for the treatment of patients with certain confirmed or suspected Gram-negative bacterial infections requiring hospitalization, is now available in the U.K. and Germany. Pfizer expects to launch…
Pfizer Commences $5 Billion Accelerated Share Repurchase
Pfizer Completes Acquisition of Small Molecule Anti-Infective Business From AstraZeneca
Pfizer completes acquisition of small molecule anti-infective business from AstraZeneca. Pfizer Inc. today announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the United States. The agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta (ceftazidime-avibactam), the marketed agents Merrem/Meronem (meropenem)…
