Takeda's Growth Plan Bears Fruit with FDA Nod for Niche Lung Cancer Drug Exkivity

Strategic Insights -

Takeda's oral med, Exkivity, has secured a conditional FDA nod for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations, marking the company's first win after several setbacks in its Wave 1 pipeline. The approval comes as a significant milestone for Takeda, which aims to rival Johnson & Johnson's Rybrevant, a bispecific antibody for the same niche patient group.

Key Takeaways:

  • Takeda's Exkivity has been granted a conditional FDA approval for non-small cell lung cancer with EGFR exon 20 insertion mutations.
  • Exkivity will compete with Johnson & Johnson's Rybrevant in the niche patient group.
  • The approval marks Takeda's first win after several setbacks in its Wave 1 pipeline.
  • Takeda's growth plan has borne fruit with the FDA nod, positioning the company for success in the competitive lung cancer market.
  • Exkivity's approval comes with certain conditions, which the company must meet to gain full approval.
  • Takeda must provide additional data to support the approval of Exkivity.

Statistics:

  • 95: Number of vials with floating material reported through September 5, according to Pfizer.
  • $108 million: Amount raised by IASO Biotherapeutics in series C funding for cell therapies, antibodies, and autoimmune disease treatment.
  • $140 million: Amount Haisco will pay to license Biosplice's phase 3 osteoarthritis drug in China.
  • 50-50: Collaboration ratio between Everest Medicines and Providence Therapeutics for mRNA platform programs.

Sources:

  • FiercePharma: "Rivaling J&J, Takeda's growth plan bears fruit with FDA nod for niche lung cancer drug Exkivity"
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  • FierceBiotech: "China's IASO nets $108M to advance cell therapies, antibodies for cancer, autoimmune disease"
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  • FierceBiotech: "Haisco to pay $140M to get the ball rolling on Biosplice's phase 3 osteoarthritis drug in China"
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