The committee reviewed data showing a 94 percent complete response rate as a third- or later-line treatment for refractory follicular lymphoma.
During 2024, the radiopharmaceutical Pluvicto achieved blockbuster status, while sales of the breast cancer drug Kisqali grew 46 percent compared to 2023.
The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.
The firms will evaluate two adjuvant treatment options, Datroway with rilvegostomig or rilvegostomig monotherapy, against standard-of-care treatment.
While the company is prioritizing RJVA-001 and a lead program in obesity, it's pausing some R&D efforts and laying off 17 percent of its workforce.
The gene-editing treatment will be available to certain patients with sickle cell disease in England as Vertex commits to collecting additional data.
The firm will share new overall survival data from the INAVO120 trial with regulators to support the breast cancer drug's approval.
The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.
The EC's decision was based on results from a Phase III trial of Blincyto with multiphase consolidation chemotherapy.
Data presented at the ASCO Gastrointestinal Cancers Symposium showed the regimen may be a new option, but it comes with more treatment and financial toxicity.
With permission from a data safety monitoring committee, the firm will begin treating a second cohort with AMT-162 in the EPISOD1 trial in early 2025.
A patient found to carry a BRCA1 pathogenic variant is not referred to a certified genetic counselor in her health system.