The U.S. Food and Drug Administration (FDA) has recently approved several treatments and diagnostic tools for lung cancer. AstraZeneca and Daiichi Sankyo's Datroway received approval for treating non-small cell lung cancer (NSCLC) in the U.S. Additionally, the FDA approved the Oncomine Dx Express Test as a companion diagnostic for Sunvozertinib in NSCLC. On June 10, the FDA granted priority review to a supplemental New Drug Application (sNDA) for the combination of lurbinectedin and atezolizumab as a first-line maintenance treatment for select patients with extensive-stage small cell lung cancer (ES-SCLC). Meanwhile, China's National Medical Products Administration (NMPA) granted breakthrough therapy designation to sacituzumab tirumotecan plus tagitanlimab for first-line treatment of locally advanced or metastatic nonsquamous NSCLC, based on the OptiTROP-Lung01 trial. Furthermore, the FDA has begun publishing Complete Response Letters (CRLs), which detail reasons for drug application rejections, including for oncology drugs such as penpulimab, toripalimab (CHRS), Fotivda, Trodelvy (GILD), and Vyloy (ALPMF). This move has been welcomed by experts who had advocated for greater transparency in regulatory decisions. The FDA also continues to monitor postmarket study requirements and commitments for approved drugs, emphasizing ongoing safety and efficacy oversight.
An FDA advisory committee review of this would've been useful. There's language on postmarket study requirements and commitments (PMRs/PMCs) that I'm not sure I've seen before in the approval letter: -We remind you that there are PMRs PMCs still open. -As described in 21 CFR https://t.co/ezwdT9FDMx
FWIW, the CRLs in FDA's newly released list concerning oncology drugs (excl generics) are for: - penpulimab - torpialimab $CHRS - Fotivda - Trodelvy $GILD - Vyloy $ALPMF
The CRLs for $SRPT, $PFE, $AMGN and other big-name ones were released in the review packages alongside the approvals ...but there are a few new ones sprinkled in https://t.co/1eoMjUKS8H