FDA submission
Iovance Biotherapeutics Shares New TIL Data in Melanoma, Projects Lifileucel FDA Filing in August
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Investors were unimpressed last week with the data they saw, though the company tried to reassure them that the findings were positive given the refractory population.
BMS Shows Breyanzi Benefit in Stem Cell Transplant-Ineligible LBCL
The new data further support the benefit of the CAR T-cell therapy as a second-line option for refractory LBCL patients.Â
Seagen Going After Tukysa, Herceptin Combo Approval in HER2-Positive Colorectal Cancer
The company plans to seek accelerated approval for the regimen after seeing a 38 percent objective response rate in the MOUNTAINEER trial.
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.