Targovax receives Fast Track designation for ONCOS-102 in melanoma
The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.
- The US FDA has granted Fast Track designation to ONCOS-102 based on the current pre-clinical and clinical data package, including mechanistic evidence showing an association between ONCOS-102-induced immune activation and tumor responses.
- Receiving this designation is an endorsement by the US FDA of the strength and importance of the ONCOS-102 data package in PD-1-refractory advanced melanoma.
- This Fast Track approval comes in addition to ONCOS-102s existing Fast Track designation in malignant pleural mesothelioma.
- Dr. Ingunn Munch Lindvig, VP Regulatory Affairs of Targovax said"Securing yet another Fast Track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need.