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FDA Approvals Roundup: Trudhesa, Brukinsa, Keytruda

Posted 08 September 2021 | By Renee Matthews 

FDA Approvals Roundup: Trudhesa, Brukinsa, Keytruda

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Trudhesa nasal spray approved for migraine
Impel NeuroPharma’s Trudhesa (dihydroergotamine mesylate nasal spray) has been approved for acute treatment of migraine with or without aura in adults. Other ergotamine formulations have been previously approved to treat migraine.
The approval was based on findings from the Phase 3, open-label STOP 301 safety study, during which more than 5,650 migraine attacks were treated with Trudhesa over 24 or 52 weeks of the study. Findings showed Trudhesa was generally well tolerated. Patient-reported exploratory efficacy findings showed that 38% of patients reported pain freedom and 66% reported pain relief, with 52% reporting freedom from their most severe migraine symptom at 2 hours after their first dose of Trudhesa.
Some patients (16%) reported rapid pain relief from 15 minutes after therapy administration. In all, 93% of patients who were pain-free at 2 hours remained pain-free at 24 hours, and 86% were still pain-free  through 2 days after administration. The therapy was also shown to be effective when taken late into a migraine attack.
New indications
Brukinsa use expanded for use in Waldenström’s macroglobulinemia
BeiGene’s Brukinsa (zanubrutinib) has received an expanded indication for treating adults with Waldenström’s macroglobulinemia.
The approval of Brukinsa was based on findings from two cohorts in the randomized, active control, open-label ASPEN trial. In Cohort 1, 199 patients with MYD88 L265P mutation Waldenström’s macroglobulinemia were randomized to receive Brukinsa or ibrutinib until disease progression or unacceptable toxicity. In Cohort 2, 26 patients with MYD88 wildtype and 2 with MYD88 mutation unknown received Brukinsa. In Cohort 1, a noncomparative assessment of response rate (defined as partial response or better) in Brukinsa patients was 77.5%, and event-free DoR at 12 months was 94.4%. The response rate for patients in Cohort 2 was 50%.
The review used the assessment aid; the application was granted fast track designation and orphan designation.
Brukinsa was first approved in 2019 for previously treated adults with mantle cell lymphoma.
Keytruda nabs full approval for bladder cancer
Merck’s Keytruda (pembrolizumab) has received full approval as a first-line therapy for adults with advanced urothelial carcinoma. The immunotherapy is also approved for treating patients with locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-containing chemotherapy or whose disease has progressed despite receiving platinum-containing chemotherapy.
The immunotherapy was previously indicated, under an accelerated approval based on tumor response rate and duration of response, for treating patients with locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed programmed death-ligand 1 (PD-L1), or in patients who were not eligible for any platinum-containing chemotherapy, regardless of PD-L1 status.
Keytruda was originally approved in 2014 for advanced melanoma and is used to treat several types of cancers, including head and neck squamous cell cancer, classical Hodgkin lymphoma.



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Tags: FDA, US

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