FDA Approvals Roundup: Xaciato, cutaquig, Rituxan

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Xaciato okayed for treating bacterial vaginosis
Daré’s Xaciato (clindamycin phosphate vaginal gel) has been approved to treat bacterial vaginosis in patients aged 12 years or older.
 
The approval was based on findings from the Phase 3 multicenter, double-blind, placebo-controlled DARE-BVFREE study in which 307 patients from the indicated population were randomized 2:1 to receive Xaciato or placebo. Test-of-cure visit data (days 21-30) showed a significantly greater percentage of Xaciato patients in the modified intent-to-treat population experienced clinical cure, bacteriological cure, and therapeutic cure compared with those receiving placebo (clinical: 70.5% vs. 35.6%, respectively; bacteriological: 43.4% vs. 5.1%; therapeutic: 36.9% vs. 5.1%). Statistically significant results for the endpoints were also achieved at an interim assessment during days 7-14 (clinical: 76.2% vs. 23.7%; bacteriological: 41% vs. 3.5%; therapeutic: 35.2% vs 0).
 
Xaciato received qualified infectious disease product (QIDP) and fast track designations for this indication. Under the QIDP designation, the drug will likely have a five-year extension to the three years of market exclusivity available to it.
 
New indications
cutaquig use extended for primary humoral immunodeficiency in children
Octapharma’s cutaquig (immune globulin, subcutaneous [Human]-hipp solution) been granted a new indication for treating children aged 2 years and older with primary humoral immunodeficiency (PI).
 
The current approval was based on findings from two clinical trials. One was a pivotal prospective, open-label, single-arm, multicenter study to evaluate cutaquig’s pharmacokinetics, efficacy, tolerability, and safety; the other was an extension study. In the pivotal trail, 75 (37 adults and 38 children) from the indicated population were randomized weekly cutaquig infusions during a 12-week wash-in/-out period followed by a 12-month efficacy period. The main objective was to assess the efficacy of cutaquig in preventing serious bacterial infections. No serious bacterial infections were reported.
 
The drug was originally approved in 2018 for treatment of primary humoral
immunodeficiency in adults. It comes with a boxed warning for thrombosis.
 
Rituxan gets new indication for lymphoma, leukemia in children
Genentech’s Rituxan (rituximab injection), combined with chemotherapy, has been granted a new indication for treating children aged 6 months to younger than 18 years who have previously untreated, advanced CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL).
 
Approval for the new indication was based on findings from the global, multicenter, open-label Inter-B-NHL Ritux 2010 study in which patients from the indicated population were randomized 1:1 to receive chemotherapy alone or in combination with Rituxan. The main efficacy outcome measure was event-free survival (EFS).
 
A prespecified interim efficacy analysis was performed at 53% information fraction in 328 randomized patients after a median follow-up of 3.1 years. In all, there were 28 EFS events in the chemotherapy group and 10 in the Rituxan-chemotherapy group. Also at the time of the interim analysis, there were 20 deaths in the chemotherapy arm, compared with 8 in the study arm, with an estimated overall survival hazard ratio of 0.36. There was no formal statistical test for overall survival. Randomization was discontinued after the interim analysis, with an additional 122 patients receiving the Rituxan-chemotherapy combination.
 
The review used the assessment aid, and the application was granted priority review.
 
Rituxan, a CD20-directed cytolytic antibody, was originally approved in 2014. It used to treat a number of diseases, including non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.
 
Keytruda use expanded to include children with melanoma
Merck’s Keytruda (pembrolizumab injection) has received a new indication for the adjuvant treatment of adults and children aged 12 years or older who have stage IIB or IIC melanoma after complete resection.
 
Approval of this new indication was based on efficacy findings from the multicenter, double-blind, placebo-controlled KEYNOTE-716 trial in which patients from the indicated population were randomized 1:1 to receive Keytruda or placebo for up to one year until disease recurrence or unacceptable toxicity. Recurrence-free survival (RFS) was the main efficacy outcome measure. Findings showed a significant improvement in RFS at the first interim analysis for patients receiving Keytruda arm compared with placebo (HR, 0.65). Median RFS was not reached in either arm.
 
The review used the real-time oncology review pilot program and the assessment aid. The application was granted priority review and orphan drug designation.
 
Keytruda, a human programmed death receptor-1‒blocking antibody, was originally approved in 2014 for use in previously treated metastatic melanoma and is used in numerous other cancers, including non-small cell lung cancer and triple-negative breast cancer.