PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review
Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.
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Final guidance targets the ‘multiplicity problem.’ At about half the length of the 2017 draft, the final removes some sections, truncates other and drops several examples.
Beam Therapeutics also announced that it dosed the first patient in its Phase I/II sickle cell disease trial; Vyne stepped into the increasingly competitive vitiligo space, while Tracon moved further into sarcomas in its checkpoint inhibitor program, and Telix started a small trial of its drug in brain cancer.
Published data showed Merck’s PD-1 inhibitor combined with Eisai’s Lenvima improved survival in the all-comer population of previously treated endometrial carcinoma.