FDA approves Pfizer's drug for advanced breast cancer
The U.S. Food and Drug Administration said on Tuesday it approved Pfizer Inc’s drug for an advanced form of breast cancer tied to an inherited gene mutation.
The U.S. Food and Drug Administration said on Tuesday it approved Pfizer Inc’s drug for an advanced form of breast cancer tied to an inherited gene mutation.
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that it has signed a commercialization plan with Pfizer Inc. The plan is under an existing companion diagnostic agreement, in which Myriad is pursuing U.S. Food and Drug Administration (FDA) approval for its BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s investigational PARP (poly ADP ribose polymerase) inhibitor, talazoparib.
Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that it has signed a commercialization plan with Pfizer Inc. The plan is under an existing companion diagnostic agreement, in which Myriad is pursuing U.S. Food and Drug Administration (FDA) approval for its BRACAnalysis CDx to be used as a companion diagnostic with Pfizer’s investigational PARP (poly ADP ribose polymerase) inhibitor, talazoparib.
Myriad Genetics, Inc. MYGN has moved one step forward in acquiring the FDA approval for the company’s BRACAnalysis CDx test to be used as a companion diagnostic with Pfizer’s PFE PARP inhibitor, talazoparib.
A couple of years back, Pfizer Inc. (NYSE:PFE) took a lot of heat in order to pull off a massive $14 billion acquisition that added Xtandi and a potential new cancer drug called talazoparib to its pipeline. At the time, America's biggest pharma quelled investor skepticism with confident boasting that talazoparib would easily outperform a handful of related treatments that it will probably end up competing with.
Pfizer Inc. (NYSE:PFE) announced on 6/7/2018 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.
Pfizer Inc. (NYSE:PFE) announced on 6/7/2018 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.