Drugs

Janssen Seeks Expanded Rybrevant Use

Janssen Pharmaceutical has submitted a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution after disease progression on or after osimertinib. “New treatment options are urgently needed in the post-osimertinib setting, where patients continue to face unacceptable survival rates,” the company says in a statement.

The submission is based on data from the Phase 3 MARIPOSA-2 (NCT04988295) study evaluating the efficacy and safety of Rybrevant and chemotherapy in patients with the specific lung cancer. Progression-free survival was significantly longer for amivantamab and chemotherapy and amivantamab/lazertinib/chemotherapy versus chemotherapy, according to the company. The objective response rate was significantly higher for amivantamab/chemotherapy and amivantamab/Lazertinib/chemotherapy versus chemotherapy (64% and 63% versus 36%, respectively).

Rybrevant was originally granted an accelerated approved 5/2021 as a single agent for treating adult patients with NSCLC whose tumors have EGFR exon 20 insertion mutations.

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