With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
With phase I/II data in hand, Taiho Pharmaceutical Co. Ltd. and Cullinan Therapeutics Inc. began filing a rolling NDA to the U.S. FDA for accelerated approval of zipalertinib to treat patients with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations who previously received platinum-based chemotherapy.
With data due later this summer from the phase II Pioneer trial testing Blueprint Medicines Corp.’s approved Ayvakit (avapritinib), many investor eyes are on the potential label expansion into indolent systemic mastocytosis – but the company has another potential ace in the hole with BLU-451, which targets EGFR exon 20 insertion mutations in non-small-cell lung cancer (NSCLC).
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.
Cullinan Oncology Inc.’s lead program deal with Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. brings $275 million up front and the potential for as much as $130 million in regulatory milestone payments.
Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 11.3% to close at $33.11 on June 4 as an update on its EGFR inhibitor, CLN-081, suggested it may prove competitive with Johnson & Johnson's recently approved treatment, Rybrevant (amivantamab), for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations.
The FDA’s approval for Johnson & Johnson (J&J) of Rybrevant (amivantamab-vmjw) not only brings the first treatment for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations, but also sets a high overall response rate bar for other developers in the space.
