Nizatidine and Ranitidine Products Recalled Due to NDMA
January 8, 2020Ayvakit Approved as First Targeted Therapy for Gastrointestinal Tumors with Rare Gene Mutation
January 9, 2020Keytruda Receives New Bladder Cancer Indication
January 8, 2020 – The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck, to treat patients who are ineligible for or have elected not to undergo cystectomy and have been diagnosed with high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with or without papillary tumors that does not respond to treatment with Bacillus Calmette-Guerin.
NMIBC is an early-stage form of bladder cancer that accounts for approximately 75% of all new bladder cancer diagnoses. While many patients can benefit from treatment with Bacillus Calmette-Guerin, a standard immunotherapy treatment, it is not always effective. Potential treatment strategies also include the surgical removal of all or part of the bladder (cystectomy), but the procedure can have significant and potentially life-threatening risks as well as a long-term negative impact on quality of life.
In a clinical study, 41% of participants responded to treatment with Keytruda, experiencing a median duration of response of 16.2 months. Within this group, 46% of patients had a complete response to therapy that lasted for at least 12 months.
Recommended dosing under the new indication is 200mg administered via intravenous (IV) infusion over the course of 30 minutes every three weeks. Treatment should continue until disease progression or unacceptable toxicity occur, until persistent or recurrent high-risk NMIBC is identified, or for up to 24 months in patients without disease progression.
First FDA approved in 2014, Keytruda now holds 25 separate indications to treat 15 different types of cancer.
