Specialty Pharma Journal Specialty, Precision & Technology
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted priority review for the approval of LYNPARZA (olaparib) (two 150 mg …
Tag Archives: PARP inhibitor
November, 2018
October, 2018
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18 October
FDA Approves Pfizer’s Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for …
June, 2018
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15 June
Pancreatic Cancer Patients with BRCA Mutation may Benefit from Targeted Drug
A physician-scientist at the University of Arizona Cancer Center investigated a novel treatment for pancreatic cancer patients whose tumors exhibited a harmful genetic mutation. The results, in which a type of drug called a PARP inhibitor showed early promise in treating pancreatic cancer in patients with mutations in the BRCA …
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7 June
Pfizer’s Talazoparib Granted FDA Priority Review for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
NEW YORK–(BUSINESS WIRE)–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) …
May, 2018
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18 May
Ovarian Cancer Drug Shows Promise in Pancreatic Cancer Patients with BRCA Mutation
PHILADELPHIA – A targeted therapy that has shown its power in fighting ovarian cancer in women including those with BRCA1 and BRCA2 mutations may also help patients with aggressive pancreatic cancer who harbor these mutations and have few or no other treatment options. An international team of researchers led by the Perelman School of Medicine and the Basser Center …
January, 2018
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12 January
FDA Approves AstraZeneca’s PARP Inhibitor to Treat Breast Cancer Patients with a BRCA Gene Mutation
The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP …
December, 2017
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20 December
Array BioPharma and Pfizer Collaborate on Novel Anti-Cancer Combinations
BOULDER, Colo., Dec. 19, 2017 /PRNewswire/ — Array BioPharma (Nasdaq: ARRY) announced today that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations, including Array’s MEK inhibitor, binimetinib, with Pfizer’s investigational PARP inhibitor talazoparib, and avelumab*, a …
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8 December
Pfizer’s Talazoparib Significantly Extends Progression-Free Survival in Patients with Metastatic Breast Cancer
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 EMBRACA trial in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced and/or metastatic breast cancer (MBC) demonstrated superior progression-free survival (PFS) in patients treated with talazoparib, compared to patients who received physician’s choice standard of care chemotherapy. Median PFS …
October, 2017
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18 October
FDA Grants Priority Review to AstraZeneca and Merck’s Lynparza in Metastatic Breast Cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of LYNPARZA® (olaparib) tablets in patients with germline BRCA-mutated …
June, 2017
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19 June
Clovis Oncology’s Ovarian Cancer Drug Succeeds in Late-Stage Study
BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) today announced topline data from the confirmatory phase 3 ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival (PFS) by investigator review in each of the three populations studied. PFS was also improved in the rucaparib group compared …