Daiichi Sankyo Receives Two Breakthrough Therapy Designations from the US FDA for Enhertu to Treat Multiple HER2 Expressing Cancers
Shots:
- The US FDA has granted 2 additional BTDs to Enhertu for adult patients with unresectable or metastatic HER2+ solid tumors and HER2+ (IHC 3+) metastatic colorectal cancer. The therapy is being jointly developed & commercialized by Daiichi Sankyo & AstraZeneca
- The BTD for metastatic HER2+ solid tumors was based on a P-II study (DESTINY-PanTumor02) in 268 patients with supporting data from other trials in the Enhertu clinical development program demonstrated durable responses, ORR (37.1%), CR (5.6%), PR (31.5%) & SD (46.1%) while DCR in the overall trial population was 68.2%, presented at ASCO 2023
- The BTD for HER2+ metastatic colorectal cancer was based on final results from the P-II trial (DESTINY-CRC01) in 86 patients showed promising activity & durability with longer-term follow-up. The safety profile was consistent with prior results, presented at ASCO GI 2022
Ref: Businesswire | Image: Daiichi Sankyo
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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.
