Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and co-developed with MSD. The CRL addresses issues identified at the third-party manufacturing facility, with no concerns raised regarding the drug’s safety or efficacy.
Patritumab deruxtecan was filed for approval to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have previously received two or more systemic therapies.
Dr. Ken Takeshaita, Global Head of R&D at Daiichi Sankyo, commented, “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.” The identity of the third-party manufacturer has not been disclosed.
The BLA submission is supported by the HERTHENA-Lung01 pivotal Phase II study, which included 225 patients with EGFR-mutated locally advanced or metastatic NSCLC. These patients had experienced disease progression following treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy. The ADC demonstrated an objective response rate (ORR) of 29.8%, including one complete response and 66 partial responses, with a median duration of response (DoR) of 6.4 months.- Flcube.com
