Drugs

NDA Filed for Zipalertinib in Lung Cancer

Cullinan Therapeutics says its partner, Taiho Oncology, has filed an NDA for zipalertinib in combination with platinum-based chemotherapy for treating patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations. he submission was made under the agency’s Real-Time Oncology Review program, which allows sponsors to submit clinical data in advance of a complete application to facilitate earlier review of efficacy and safety results.

The NDA is based on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint at an interim analysis, “demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) for zipalertinib plus chemotherapy versus chemotherapy alone,” the company says.

Zipalertinib is described as an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, according to the company.

FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

FDA Oncology Center of Excellence director Angelo De Claro says the center has retained its core regulatory experts despite staffing reductions across the agency and is pursuing new collaborations with the Department of Veterans Affairs and National Cancer Institute to modernize oncology clinical trials. Speaking during an 11/10 fireside

AdvaMed on Digital Breast Tomosynthesis Reclassification

AdvaMed says it is not taking a position on an FDA proposal to reclassify digital breast tomosynthesis systems from Class 3 into Class 2, but does have implementation concerns if the reclassification is approved. In its comment letter, the trade group says, “If FDA finalizes the proposed order, a clear,

FDA Posts 20 Form 483 Inspection Records

FDA has posted 20 Form 483 inspection records (see below), including reports involving sterile drug manufacturer Huons in South Korea, Bora Pharmaceutical Laboratories in Taiwan, Genzyme Ireland, Similasan in Switzerland, and medical device manufacturers in the U.S. and overseas. Their availability is part of the agency’s expanded transparency

Modest Device Material Change May Need New 510(k): Post

Even seemingly modest medical device material changes such as new colorants, a different preservative, or a reformulated component sourced from a new supplier, may require submission of a new 510(k) to FDA. That’s the advice from principal medical device regulation expert Adrienne Lentz (Hyman, Phelps & McNamara) in

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FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

AdvaMed on Digital Breast Tomosynthesis Reclassification

FDA Posts 20 Form 483 Inspection Records

Modest Device Material Change May Need New 510(k): Post