Drugs

Imfinzi OK’d for Resectable Lung Cancer

FDA has approved AstraZeneca’s Imfinzi (durvalumab) with platinum-containing chemotherapy as neoadjuvant treatment that is followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors greater than 4 cm or node positive) non-small cell lung cancer (NSCLC). The drug is intended for use in those with no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, according to an FDA release.

Approval was based on date from the company’s AEGEAN (NCT03800134) trial in 802 patients with previously untreated and resectable squamous or non-squamous NSCLC (Stage IIA to select Stage IIIB), the agency says. Patients were administered either durvalumab or placebo, with platinum-based chemotherapy, every three weeks for up to four cycles followed by either continued single-agent durvalumab or placebo for up to 12 cycles (adjuvant treatment), it says.

The trial’s efficacy outcome measures were event-free survival (EFS) and pathological complete response (pCR). FDA says median EFS was not reached, and the pCR rate was 17% and 4.3% in the durvalumab and placebo arms, respectively. “At the time of the prespecified interim analyses, overall survival (OS) was not formally tested for statistical significance; however, a descriptive analysis revealed no clear detriment,” it adds.

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