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FDA Approvals Roundup: Rylaze, Solosec, Keytruda

Posted 07 July 2021 | By Renee Matthews 

FDA Approvals Roundup: Rylaze, Solosec, Keytruda

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Rylaze cleared for leukemia and lymphoma in adults and children
Jazz Pharmaceuticals’ Rylaze (asparaginase erwinia chrysanthemi [recombinant]-rywn, intramuscular injection) has been approved as a component of a multiagent chemotherapeutic regimen for treating acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and children, aged 1 month or older, who are hypersensitive to E. coli-derived asparaginase.
Rylaze’s approval was based on efficacy findings from the open-label, multicohort, multicenter Study JZP458-201 in 102 patients from the indicated population who were treated with the antineoplastic agent. The median age was 10 years (range, 1-24 years). The primary efficacy outcome measure was achievement and maintenance of a nadir serum asparaginase activity (NSAA) level above 0.1 U/mL, which is associated with serum asparagine depletion and considered therapeutic. Modeling and simulations data showed 93.6% of patients were able to maintain the therapeutic level 48 hours after a dose of Rylaze.
The review for this application was conducted under Project Orbis and in collaboration with Health Canada. This review used the real-time oncology review pilot program and the assessment aid. The agency granted the application fast track and orphan drug designations.
New indications
Solosec gets expanded indication for trichomoniasis
Lupin’s Solosec (secnidazole oral granules) has been granted an expanded indication for treating adults with trichomoniasis vaginalis, the most common nonviral, curable sexually transmitted infection (STI) in the US. 
The antimicrobial agent is the only single-dose, oral prescription therapy approved for treating both trichomoniasis and bacterial vaginosis, for which it was first approved in 2017. Sexual partners should be treated with the same dose, at the same time to prevent trichomoniasis reinfection.
Solosec’s approval was based on safety and efficacy findings from a Phase 3, multicenter, prospective, randomized, placebo-controlled study in 147 patients. There was a cure rate of 92.2% among the 64 patients treated with Solosec, a statistically significant difference compared with the 67 patients receiving placebo in the modified intent-to-treat population consisting of patients with trichomoniasis and no other sexually transmitted infections (P < .001).
Approval of Solosec for treating trichomoniasis in men was granted based on four open-label trials in men – a comparative study with metronidazole and ornidazole in men only, and three single-arm studies in men and women. Reported cure rates ranged from 91.7% to 100%.
Keytruda gets extension for use in advanced cutaneous SCC
Merck’s Keytruda (pembrolizumab IV injection) has been granted an expanded indication as a monotherapy for treating patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The approval of the anti-programmed death receptor-1 (PD-1) therapy was based on findings from the  multicenter, multicohort, nonrandomized, open-label KEYNOTE-629 study in patients with recurrent/metastatic or locally advanced cSCC. They received the study drug every 3 weeks, until disease progression or unacceptable toxicity. Major efficacy outcome measures were overall response rate (ORR) and duration of response (DoR).
Patients receiving the study drug (n = 54%) had an ORR of 50% (complete vs partial response, 17% vs 33%, respectively). Among the 27 responding patients, 81% had a DoR of 6 months or longer, and 37% had a DoR of 12 months or longer.
Keytruda was first approved in 2014 for treating melanoma and is used to treat several types of cancers, including non-small cell lung and triple-negative breast cancers.


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Tags: FDA, US

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