FDA submission
Allarity Therapeutics Submits NDA for Dovitinib for Treating Certain Renal Cancer Patients
The company is seeking marketing approval for dovitinib alongside its companion diagnostic Dovitinib-DRP.
AstraZeneca, Merck File Adjuvant Lynparza sNDA for Early-Stage Breast Cancer
The FDA is evaluating the application for the PARP inhibitor in BRCA1/2-mutated early-stage breast cancer and may make a decision in early 2022.
Mirati Therapeutics Submits IND to FDA for PRMT5 Inhibitor in MTAP-Deleted Cancers
If the FDA approves the application, Mirati will begin evaluating the agent in a Phase I/II clinical trial for cancers harboring MTAP gene deletions.
Novartis Seeking FDA, EMA Kymriah Approval for Follicular Lymphoma
The firm submitted applications to both US and European regulators for its autologous CAR T-cell therapy tisa-cel in relapsed or refractory follicular lymphoma.
Agencies and drugmakers are struggling to generate consistent standards and regulatory criteria for evaluating autologous cell therapies.