Oncopeptides’ Pepaxti (melphalan flufenamide) Receives the EC’s Approval for the Treatment of Multiple Myeloma
Shots:
- The EC has granted marketing authorization for Pepaxti in combination with dexamethasone for adult patients with MM who have received three prior lines of therapies
- The marketing authorization was based on the P-II (HORIZON) study to evaluate melflufen + dexamethasone in 157 patients with r/r MM & was also based on the P-III (OCEAN) study. The product is expected to be launched in Q4’22
- The results from the P-II (HORIZON) study showed ORR (28.8%), DoR (7.6mos.), TTR (2.3mos.). The company plans to submit a type II variation in Q4’22 for earlier lines of treatment & the EC’s marketing authorization is valid in all EU member states, EEA countries Iceland, Lichtenstein & Norway
Ref: PR Newswire | Image: Sanofi
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
