Daiichi Sankyo and AstraZeneca does a Batman & Robin act and fires off its second ADC shot of 2024 with another FDA BLA for Dato-DXd

Daiichi Sankyo and AstraZeneca does a Batman & Robin act and fires off its second ADC shot of 2024 with another FDA BLA for Dato-DXd

It’s no secret I am very fond of ADCs and I have previously said that 2024 could be a ”hot” year for ADCs.  I’m wondering if I’m seriously wrong.  I’m now convinced 2024 may just be the start and ADCs will continue to peak through 2025, 2026 and probably through 2027.  Look at the amount of ADC paperwork from just 2 companies that the FDA has got to deal with in the first quarter of 2024, and I’m embarrassed to say I may have been far too conservative in my appreciation of the value of ADCs.  So let me confess all during this Easter week.

Today, 2nd April 2024, we get news from the dynamic ”Batman and Robin duo” of Daiichi Sankyo and AstraZeneca (DS & AZ) that their BLA application for datopotamab deruxtecan (Dato-DXd) for previously treated metastatic HR-positive, HER2-negative breast cancer has been received by the FDA, with an anticipated PDUFA regulatory decision slated for 1Q2025.  This BLA is based on currently available results from the pivotal TROPION-Breast01 Phase III trial where the dual primary endpoints of PFS and OS are already clinically meaningful and still maturing.  But let’s not forget that this isn’t the first shot from DS & AZ in 2024.  On the 19th February 2024, DS & AZ fired its first shot with a BLA for Dato-DXd for non-small cell lung cancer, based on the TROPION-Lung01 study, and with an anticipated PDUFA decision of 4Q2024 and hopefully a nice Christmas present to DS & AZ.  And we can expect more to come from the TROPION study series, where a whole range of cancers are being looked at.  Some of these studies have already completed recruiting and others are still recruiting, so we can expect a conveyor belt of results streaming to the FDA.  This is absolutely marvellous news for the collaboration between these 2 pharma giants.  What a success story!

Looking back on this historical collaboration, can you believe this is literally only 5 years old??  It was exactly on the 28th March 2019 that AstraZeneca announced it had entered into a global development and commercialisation collaboration agreement with Daiichi Sankyo for trastuzumab deruxtecan (DS-8201), then a proprietary antibody-drug conjugate (ADC) and potential new targeted medicine for cancer treatment.  5 years on, how this collaboration has spawned a second-generation ADC in Dato-DXd.

I do marvel at this Batman & Robin act and it looks like they’re really going all out to save the world!

READ THE ARTICLE – https://www.astrazeneca.com/media-centre/press-releases/2024/fda-accepts-dato-dxd-bla-for-breast-cancer.html#:~:text=AstraZeneca%20and%20Daiichi%20Sankyo%E2%80%99s%20Biologics%20License%20Application%20%28BLA%29,prior%20systemic%20therapy%20for%20unresectable%20or%20metastatic%20disease.

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