FDA Updates: Keytruda Nabs Full Approval for Bladder Cancer and a Therapy for Schizophrenia is Approved


Approvals for a twice-yearly schizophrenia therapy and a seizure drug for infants, a full approval for Keytruda, and a revised EUA for a COVID-19 therapy round out the week.

Keytruda receives full approval as first-line treatment in bladder cancer.

The FDA has provided full approval for Merck’s Keytruda (pembrolizumab) for first-line advanced urothelial carcinoma. Previously, Keytruda was given accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy or for patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status

The indication on the label has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy.

The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor despite a confirmatory trial that found that Keytruda did not meet the end points of overall survival and progression-free survival. Panelists who voted for keeping the indication suggested that because Keytruda is active as a second-line treatment for patients with platinum-refractory urothelial carcinoma, it could be argued that it is active in the second-line setting.

FDA approves twice-a-year therapy for schizophrenia

The FDA has approved Janssen’s long-acting atypical antipsychotic Invega Hafyera (paliperidone palmitate), the first-and-only twice-yearly injectable for the treatment of schizophrenia in adults.

The approval is based on the results of a 12-month, non-inferiority phase 3 study that enrolled 702 adults from 20 countries. The results showed non-inferiority of Invega Hafyera compared with Invega Trinza, which is given every three months. Results found that 92.5% of patients treated with Hafyera and 95% treated with Trinza were relapse-free at 12 months.

Safety was consistent between both products with most common adverse events being upper respiratory tract infection (12%), injection site reaction (11%), weight increase (9%), headache (7%), and parkinsonism (5%).

FDA approves seizure drug for infants.

The FDA has approved an expanded indication for UCB’s Briviact (brivaracetam) tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age. This is the first time that the IV formulation will be available for pediatric patients when oral administration is temporarily not feasible and is the only IV formulation FDA-approved to treat partial-onset seizures in children one month of age and older in nearly seven years.

It was approved as monotherapy for adults in September 2017, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2018. Briviact is available in three formulations: oral tablets, oral solution, and intravenous injection.

FDA revises EUA for COVID-19 therapy.

The FDA has revised the Emergency Use Authorization (EUA) for Lilly’s bamlanivimab and etesevimab to be administered only in the 22 states in which recent data show the frequency of variants resistant to bamlanivimab and etesevimab is less than or equal to 5%.

The monoclonal antibody combination is authorized for use in states where the frequency of variants resistant to bamlanivimab and etesevimab administered together exceeds 5%. The FDA has a list of the states in which the therapy is authorized here. The therapy received an EUA for use in mild-to-moderate COVID-19 and not for patients who are hospitalized or require oxygen therapy.

Regulatory officials indicated they will update the list of authorized states based on current variant frequency data from the Center for Disease Control, trends in variant frequency over time, the precision of the estimates and information regarding emerging variants of concern.

Results from in vitro assays suggest the bamlanivimab/etesevimab was not active against the Gamma, Beta and Delta variants. The Delta variant is the dominant variant in the United States, and the frequency of identified variants expected to be resistant to bamlanivimab and etesevimab administered together is steadily decreasing.

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