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Keytruda, Opdivo Set To Challenge Tecentriq In Bladder Cancer

 
• By Emily Hayes

Phase III trial of Merck's Keytruda stops early with survival benefit as FDA accepts filing of Bristol's Opdivo, which has breakthrough therapy status and priority review.

The days may be numbered for Roche's Tecentriq as the only programmed death inhibitor in the market for bladder cancer following FDA’s acceptance of a filing for Bristol-Myers Squibb Co.'s Opdivo and positive Phase III data in the KEYNOTE-045 study of Merck & Co. Inc.'s Keytruda.

Merck announced Oct. 21 that the KEYNOTE-045 study of its PD-1 inhibitor Keytruda (pembrolizumab) in 542 patients with previously treated...

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More from Anticancer

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

Merck Scores US FDA Approval For Subcutaneous Keytruda Qlex

 
• By Alaric DeArment

The agency approved the subcutaneous formulation of the PD-1 inhibitor, months after approving a subcutaneous version of BMS’s Opdivo.

Regeneron To Pit Lynozyfic Against J&J’s Darzalex In Smoldering Myeloma

 
• By Alaric DeArment

The drugmaker presented positive Phase II data for its BCMAxCD3-directed bispecific in high-risk smoldering myeloma patients.

Nanobiotix/J&J Early Melanoma Data Show Potential For Future Indication

 
• By Mandy Jackson

Radiotherapy enhancer JNJ-1900 (NBTXR3) generated a 47% ORR and 78.9% DCR in melanoma patients after multiple prior rounds of treatment. Discussions about development in additional cancers are ongoing with partner J&J.

More from Therapy Areas

Roche’s evERA Giredestrant Study Hits In All-Comer Breast Cancer Population

 
• By Alexandra Shimmings

The Phase III trial of the SERD has shown a significant benefit in the intent-to-treat and ESR1-mutated populations in post-CDK ER+/HER2- metastatic breast cancer but whether the data will be enough to support an equally broad approval remains to be seen.

Sanofi’s Pipeline Pressure Continues As Tolebrutinib Trips Near Finish Line

 
• By Manas Mishra

Sanofi’s MS hopeful tolebrutinib hits a regulatory hurdle in the US, renewing pressure on the firm’s pipeline. Analysts hope the delay won’t prove material.

Why India Revoked The Entresto Patent And Novartis Abstained From Proceedings

 
• By Anju Ghangurde

India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.