US backs only one of two Daiichi oncology projects, but this is only the beginning 

Endorsement by an FDA advisory committee for one of the two oncology drugs that Daiichi Sankyo had up for review gives the Japanese pharma’s cancer ambitions a small boost. The panel voted in favour of pexidartinib for a rare tumour of the tendon sheaths, but against quizartinib for an aggressive form of acute myeloid leukaemia. Neither agent is seen as having substantial prospects – sales forecasts for quizartinib are certainly heading south – but there is much more to come from Daiichi in oncology. The company recently signalled a boost to investment into its pipeline of antibody-drug conjugates; the lead asset here is the Astrazeneca-partnered DS-8201, a Her2-targeted project that could be filed for US approval later this year (Astra and Daiichi lay out their plan for a better Herceptin, May 8, 2019). Earlier-stage ADCs from Daiichi will be on show at Asco next month: phase I lung cancer data on both US-1402, an anti-Her3 agent, and DS-1062, which hits Trop2, are slated for presentation. Investor meetings being held alongside the cancer conference will be scrutinised for any insight into a new business plan, which executives have also promised to deliver. Yesterday’s FDA panel looks to mark the beginning of a busy period for Daiichi Sankyo’s oncology division. 

Daiichi Sankyo's oncology efforts
      Annual Sales WW ($m)
Product Mechanism  Originator/licensee 2020 2022 2024
Quizartinib FLT 3 inhibitor Ambit Biosciences 84 185 263
Pexidartinib CSF-1R, c-kit & FLT 3 inhibitor Plexxikon 51 114 169
      135 299 432
  Phase III          
DS-8201 (trastuzumab deruxtecan) Anti-Her2 ADC Astrazeneca 50/50 profit share 100 741 1,790
  Phase I/II          
U3-1402 Anti-Her3 ADC Daiichi Sankyo - 35 75
DS-1062 Anti-Trop 2 ADC  Daiichi Sankyo - - -
DS-1647 HSV 1 oncolytic virus  Daiichi Sankyo - - -
PLX2853 BRD 4 inhibitor Plexxikon      
DS-3032 (milademetan) MDM 2 inhibitor Rigel Pharmaceuticals      
DS-3201 (valemetostat) EZH 1 & 2 inhibitor Daiichi Sankyo - - -
DS-1001 IDH 1 inhibitor Daiichi Sankyo - - -
Yescarta Anti-CD19 CAR-T  Gilead  - - -
DS-1205 AXL inhibitor Daiichi Sankyo -    
Note: Not all products have attracted sellside sales forecasts. Source: EvaluatePharma. 

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