Acceptance of the New Drug Application is based on findings from a phase 2b portion of the open-label REZILIENT1 clinical trial.

Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Applicatio ...

The FDA has accepted a new drug application (NDA) for zipalertinib for the treatment of patients with locally advanced or ...

The agency is slated to decide whether to grant accelerated approval to the drug for treating NSCLC patients with EGFR exon 20 insertion mutations by February 2027.

Of particular interest were novel therapies for EGFR exon 20 insertion mutations in non-small cell lung cancer, which ...

In a primary efficacy population of 85 patients, the confirmed overall response rate was 46%. The Food and Drug Administration (FDA) has granted accelerated approval to Zegfrovy ® (sunvozertinib) for ...

Sunvozertinib is the first targeted oral treatment for NSCLC with EGFR exon 20 insertion mutations, approved for post-chemotherapy progression cases. The WU-KONG1 Part B study showed a 53.3% objective ...

FDA NDA acceptance positions zipalertinib for post-systemic-therapy EGFR ex20ins NSCLC, with a February 27, 2027 PDUFA target ...

Zegfrovy (sunvozertinib) received accelerated FDA approval for NSCLC patients with EGFR exon 20 insertion mutations post-platinum-based chemotherapy progression. The Oncomine Dx Express Test was ...

The FDA has accepted Cullinan Therapeutics and Taiho Pharmaceutical’s application for zipalertinib, an oral therapy for advanced non-small cell lung cancer with EGFR exon 20 insertion mutations. The ...

Please provide your email address to receive an email when new articles are posted on . Researchers did not observe insertional mutagenesis of CAR-T products among patients who developed secondary ...