Clinical Trial News

FDA issues Complete Response Letter for Daiichi Sankyo and Merck's patritumab deruxtecan BLA due to inspection findings at a third-party manufacturer, without issues identified with efficacy or safety data. Patritumab deruxtecan is a potential first-in-class HER3-directed ADC, jointly developed by Daiichi Sankyo and Merck, aiming to treat EGFR-mutated NSCLC patients previously treated with two or more systemic therapies.

AbbVie received a Complete Response Letter from the FDA for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease, due to observations during inspection of a third-party manufacturer. The CRL does not raise issues on safety, efficacy, or labeling of ABBV-951.

Ionis Pharmaceuticals' olezarsen NDA accepted for Priority Review by FDA for FCS treatment, with action date set for December 19, 2024. Phase 3 sHTG program enrollment completed. Olezarsen targets apoC-III to lower triglyceride levels, reducing acute pancreatitis risk in FCS and sHTG patients.

KalVista submits NDA to FDA for sebetralstat, an oral on-demand treatment for HAE, based on phase 3 trial results showing faster symptom relief than placebo. The drug is well-tolerated with no treatment-related SAEs. FDA has a 60-day review period, with potential approval leading to the first oral on-demand HAE therapy.

Iterum Therapeutics' NDA resubmission for oral sulopenem to treat uncomplicated urinary tract infections in adult women is accepted by the FDA, with a PDUFA action date of October 25, 2024.

Astellas' resubmission of the Biologics License Application (BLA) for zolbetuximab, a CLDN18.2-targeted monoclonal antibody for first-line treatment of HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, has been acknowledged by the U.S. FDA, setting a new action date of November 9, 2024.

Milestone Pharmaceuticals announced the FDA accepted their New Drug Application for Cardamyst (etripamil) nasal spray, intended for paroxysmal supraventricular tachycardia (PSVT) management. The PDUFA target date is set for 10 months after the acceptance date. Cardamyst aims to provide a new, convenient treatment option for PSVT patients, potentially allowing self-management without medical supervision.

FDA grants Priority Review to Roche's inavolisib for advanced HR+/HER2- breast cancer with PIK3CA mutation, based on Phase III INAVO120 results showing significant progression-free survival benefits.

Atara Biotherapeutics submits a Biologics License Application to the FDA for tabelecleucel (tab-cel®) as monotherapy for EBV+ PTLD patients who have received at least one prior therapy, with no FDA approved therapies in this setting. Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells, supported by pivotal data from over 430 patients. The therapy has Breakthrough Therapy and orphan drug designations, and has received marketing authorization in Europe, UK, and Switzerland under the brand name Ebvallo™.

Yorvipath (palopegteriparatide) is FDA approved for hypoparathyroidism. Ascendis Pharma's review period for TransCon PTH extended to August 14, 2024.