FDA Approvals Roundup: Xalkori, Darzalex Faspro, Enhertu

| 20 January 2021 | By Renee Matthews 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New indications
Xalkori gets expanded indication for advanced anaplastic large-cell lymphoma in young patients
Pfizer’s Xalkori (crizotinib) has been approved for treating relapsed or refractory systemic, ALK-positive anaplastic large cell lymphoma (ALCL) in patients aged 1 to 21 years. The drug’s safety and efficacy has not been established in older adults with the same indication.
Xalkori’s approval for younger patients was based on efficacy findings from the multicenter, single-arm, open-label ADVL0912 study with 122 patients. Of those patients, 26 had relapsed or refractory, systemic ALK-positive ALCL after at least one previous systemic treatment and received the study drug twice daily until disease progression or they experienced unacceptable toxicity (median exposure, 5.4 months). Objective response rate in the 26 patients was 88% (23 patients; 95% confidence interval, 71-96%), of whom 81% had complete remission. Of the 23 responders, 39% had a response duration of at least 6 months, and 22%, of at least 12 months.
The review used the assessment aid. The application received priority review and breakthrough and orphan drug designations.
Xalkori was first approved in 2011 for treating metastatic, ALK- or ROS1-positive non-small cell lung cancer.

Darzalex Faspro wins accelerated approval for newly diagnosed light chain amyloidosis
Janssen Biotech’s Darzalex Faspro (daratumumab plus hyaluronidase injection) combined with bortezomib, cyclophosphamide, and dexamethasone has received accelerated approval for patients with newly diagnosed light chain (AL) amyloidosis.
Approval of Darzalex Faspro was based on efficacy findings from the open-label, randomized, active-controlled ANDROMEDA trial with 388 patients with newly diagnosed AL amyloidosis. Participants were randomized to receive bortezomib, cyclophosphamide, and dexamethasone alone or combined with Darzalex Faspro (median duration of treatment, 5.3 vs. 9.6 months, respectively). Hematologic complete response rate was 42.1% for the study group and 13.5% for the control group (odds ratio, 4.8; 95% CI, 2.9-8.1; P < .0001).
The application was granted accelerated approval on the response rate. Continued approval for the indication will be contingent on follow-up data on clinical benefit from confirmatory trials.
Review of the application was conducted in collaboration with four of the FDA’s six international partners under Project Orbis – the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Swissmedic. The review used the real-time oncology review pilot program and the assessment aid.
Darzalex Faspro was first approved in 2020 for treating adults with multiple myeloma.

Enhertu okayed for HER2-positive gastric adenocarcinomas
Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) has received an expanded indication for treating locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma in patients previously treated with a trastuzumab-based regimen.
The approval was based on findings from the multicenter, open-label, randomized DESTINY-Gastric01 trial in 188 patients from the indicated population. The participants were randomized 2:1 to receive Enhertu or either irinotecan or paclitaxel monotherapy. Overall survival was 12.5 months in the Enhertu arm and 8.4 months in the irinotecan or paclitaxel arm (P = .0097). Objective response rate was 40.5% in the study drug arm and 11.3% in the irinotecan/paclitaxel arm. Median progression-free survival was 5.6 and 3.5 months, respectively, and median duration of response was 11.3 and 3.9 months, respectively.
The review used the assessment aid. The application received priority review and breakthrough therapy and orphan drug designations in gastric cancer.
Enhertu was first approved in 2019 for previously treated adults with unresectable or metastatic HER2-positive breast cancer.


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Tags: FDA, US

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