FDA approves Merck’s bladder cancer drug

The US Food and Drug Administration (FDA) has approved two new indications for Merck’s (known as MSD outside the US and Canada) Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

In the first-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumour response rate and duration of response.

Continued approval

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In the second-line setting, Keytruda is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Keytruda is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

Adverse effects

Immune-mediated adverse reactions occurred with Keytruda including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Based on the severity of the adverse reaction, the drug should be withheld or discontinued and corticosteroids administered if appropriate. It can also cause severe or life-threatening infusion-related reactions. Monitor patients for signs and symptoms of infusion-related reactions; for Grade 3 or 4 reactions, stop infusion and permanently discontinue. Based on its mechanism of action, Keytruda can cause foetal harm when administered to a pregnant woman. Female patients of reproductive potential should be advised of the potential hazard to a fetus.

"These two indications mark important additions to the growing list of tumours and treatment settings for which KEYTRUDA is now approved. This FDA approval further demonstrates Merck’s commitment to help improve the lives of patients with many types of advanced cancer," said Dr Roger Perlmutter, President, Merck Research Laboratories.

The clinical development program includes more than 30 tumour types in nearly 500 clinical trials, including more than 250 trials that combine Keytruda with other cancer treatments. Currently, Merck has the largest immuno-oncology clinical development program in bladder cancer, with 29 trials underway involving Keytruda as monotherapy and in combination, including four registration-enabling studies.