FDA Rejects Merck-Daiichi Sankyo’s Lung Cancer Drug, Approves New Treatments for COPD and Lymphoma

1. FDA Rejects Merck-Daiichi Sankyo's Lung Cancer Drug: The FDA issued a Complete Response Letter (CRL) for patritumab deruxtecan, a potential first-in-class HER3-directed antibody-drug conjugate for non-small cell lung cancer (NSCLC), citing issues with a third-party manufacturing facility inspection.
2. COPD Treatment Approved: Verona Pharma's ensifentrine, a dual inhibitor of phosphodiesterase 3 and 4 enzymes, received approval for the maintenance treatment of chronic obstructive pulmonary disease (COPD), offering a novel mechanism for COPD treatment.
3. Lymphoma Treatment Approved: AbbVie and Genmab's bispecific antibody Epkinly (epcoritamab) was approved for the treatment of relapsed or refractory follicular lymphoma (R/R FL).
4. Patritumab Deruxtecan's Clinical Trial Results: The HERTHENA-Lung01 pivotal phase 2 trial demonstrated an objective response rate of 29.8% and a median duration of response of 6.4 months in patients with advanced or metastatic NSCLC.
5. Manufacturing Issues: The CRL for patritumab deruxtecan did not identify any issues with the efficacy or safety data submitted, but rather with the third-party manufacturing facility inspection.