Drugs

Boehringer Drug Shows Encouraging Data in Lung Cancer

Boehringer Ingelheim has released new findings from its Beamion LUNG-1 trial, highlighting the potential of zongertinib as a breakthrough oral therapy for patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 mutations.

The trial focused on patients with advanced NSCLC who had previously received treatment and whose tumors carry activating HER2 mutations, particularly in the tyrosine kinase domain, according to the company. Among the 75 patients evaluated, the objective response rate was 71%, including a 7% complete response rate and a 64% partial response rate. The disease control rate reached 96%, with median duration of response at 14.1 months and median progression-free survival at 12.4 months, it says.

“This trial suggests zongertinib may offer a new approach to treating patients with non-small cell lung cancer with activating HER2 mutations,” said study investigator and MD Anderson Cancer Center’s rhoracic/head and neck medical oncology chair John Heymach. “More than 70% of patients experienced a tumor response, which is highly meaningful. If approved, zongertinib would be the first oral, targeted treatment option for this subgroup.”

Zongertinib also demonstrated intracranial activity, with 41% of 27 evaluable patients with brain metastases responding to treatment and 81% achieving disease control, the company says.

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