FDA Breakthrough Therapy Designation has been granted to PADCEV™ in combination with pembrolizumab in first-line advanced bladder cancer.
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The drug’s developers reveal Keytruda increased progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) expressing PD-L1.
NICE has asked for more information on Keytruda (pembrolizumab) for untreated metastatic or unresectable recurrent squamous cell head and neck cancer due to uncertainty over clinical trial evidence.
Keytruda is the first anti-PD-1 monoclonal antibody therapy approved for patients with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer.
The European Commission has given its approval to Keytruda to treat head and neck squamous cell carcinoma as a monotherapy or in combination with a chemotherapy.
Sales of Merck’s drug Keytruda have grown beyond those of Bristol-Myers Squibb’s Opdivo, to become the global leading PD-1 inhibitor.
A new initiative has already collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in three countries.