EMA and FDA accepted regulatory submissions for Pfizer’s cancer drug

| By | Cancer Drugs, Drug Development, EMA, FDA
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Pfizer announced 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 European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib in this patient population.

Talazoparib is an investigational anti-cancer medicine called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage.

Talazoparib is currently being evaluated in advanced gBRCAm breast cancer and early triple negative breast cancer as well as DNA damage repair (DDR)-deficient prostate cancer and in combination with immunotherapy in various solid tumor types. Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

Pfizer Oncology has growing pipeline of biologics, small molecules and immunotherapies that is focused on identifying and translating the best scientific breakthroughs into clinical application for patients across a diverse array of solid tumors and hematologic cancers. Currently, Pfizer Oncology has 10 approved oncology medicines and 14 assets currently in clinical development.

SOURCE: pfizer
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