…………….catching up with FDA approvals
The FDA has approved a new infused therapy, Tevimbra (tislelizumab-jsgr) from BiGene, indicated for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Tevimbra belongs to the class of medicines known as checkpoint inhibitors and works by blocking the PD-1 pathway to help prevent cancer cells from being shielded from the immune system, increasing the immune system’s response. Tevimbra is highly specific for PD-1 and is a type of immunotherapy (immune checkpoint inhibitor) and a type of targeted therapy (monoclonal antibody).
Tevimbra faces well established competition in the esophageal cancer indication including Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo.
Tevimbra is expected to launch in the 2nd half of 2024.
Pricing for Tevimbra has yet to be confirmed but analysts suggest that it will launch with a discount of ~20% below Keytruda.
The company did not release distribution details.
CLICK HERE to access prescribing information
——————————————————————————————-
BeiGene finally snags FDA approval for PD-1 drug Tevimbra after long delay, Novartis breakup
- BeiGenePD-1/L1FDA approvalsimmuno-oncology
- eiGene would have enjoyed Big Pharma support for Tevimbra from Novartis, but the two firms parted ways in September. (Hopewell/BeiGene)
- Twenty months after the FDA’s original target decision date on cancer drug tislelizumab, BeiGene has finally received the U.S. go-ahead.
