Drugs

Pfizer Says Talzenna Prostate Cancer Study ‘Positive’

Pfizer says data from the Phase 3 TALAPRO-2 study show a statistically significant and clinically meaningful 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with Talzenna (talazoparib) plus Xtandi (enzalutamide). The company also reported that FDA has granted priority review for its sNDA for Talzenna in combination with Xtandi to treat men with metastatic castration-resistant prostate cancer.

The statement says the drug combination is also being investigated in the TALAPRO-3 trial in men with homologous recombination repair-deficient metastatic castration-sensitive prostate cancer.

Talzenna is described as an oral poly ADP-ribose polymerase inhibitor that plays a role in DNA damage repair. It has been approved by FDA to treat adults with some breast cancers.

Xtandi is described as an androgen receptor inhibitor that is indicated in the U.S. to treat patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome