来源: Pharmaceutical Technology
The safety profile of the product in the Phase II trial was consistent with previous trials in NSCLC. Credit: Jo Panuwat D/ Shutterstock. The regulator highlighted inspection findings at a third-party manufacturing facility.
Daiichi Sankyo research and development global head Ken Takeshita stated: “We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3-directed medicine to patients with previously-treated EGFR-mutated non-small cell lung cancer. 来源: Pharmaceutical Technology
FDA go-ahead for Verona Ohtuvayre transforms US COPD exacerbator market 来源: Pharmaceutical Technology
“We remain confident in the ability to develop this medicine to its full potential.”
The BLA was based on initial results from the multicentre, global, open-label, two-arm Phase II HERTHENA-Lung01 clinical trial which assessed the drug’s safety and efficacy in 225 patients.
The study demonstrated an objective response rate of 29.8%, including one complete response and 66 partial responses, with a median duration of response of 6.4 months.
Merck Research Laboratories global clinical development oncology head and senior vice-president Marjorie Green stated: “Patients with previously treated EGFR-mutated non-small cell lung cancer often experience recurrence and have limited treatment options. “We are committed to working with Daichi Sankyo and the FDA to prioritise making patritumab deruxtecan available to these patients in need.” In January 2024, MSD signed a definitive agreement to acquire Harpoon Therapeutics for $680m, strengthening its immunotherapy portfolio for cancer treatment.