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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 3 days ago
- 2 min read
01/12/2025
Cullinan Therapeutics' CLN-049 received the FDA fast track designation for R/R Acute Myeloid Leukemia (Ref)
The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for the treatment of relapsed/refractory acute myeloid leukemia.
Results from the Phase 1 clinical trial of CLN-049 will be presented at 67th ASH Annual Meeting (Dec 08)
Jeffrey Jones, CMO, Cullinan Therapeutics: “Fast Track designation underscores both the urgent need for new options in relapsed and refractory acute myeloid leukemia and the promise of CLN-049. Initial results from our Phase 1 study have shown meaningful efficacy, including complete responses, reinforcing the broad potential of this FLT3-directed T cell engager in a population where effective treatment options are currently limited and fragmented. This regulatory milestone provides important momentum for development, and we look forward to collaborating closely with the FDA to rapidly advance CLN-049 for patients who desperately need more effective therapies.”
Astellas Pharma and Pfizer's Type II variation application for perioperative enfortumab vedotin + pembro has been valiated by the EMA (Ref)
The EMA validated for review, a Type II variation application for Astellas Pharma and Pfizer's enfortumab vedotin (PADCEV; Nectin-4 directed ADC) + pembrolizumab as a neoadjuvant treatment, and then continued after radical cystectomy as adjuvant treatment, for adults with MIBC who are ineligible for cisplatin-containing chemotherapy.
The Type II variation application is based on results from the Phase 3 EV-303/KEYNOTE-905 trial
The EMA’s CHMP and subsequently the EC are expected to share their opinion and decision on the Type II variation application in the calendar year 2026
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