Regulatory Focus™ > News Articles > 2021 > 9 > FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

Posted 22 September 2021 | By Renee Matthews 

FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Exkivity okayed as oral therapy for advanced NSCLC with certain mutations
Takeda’s Exkivity (mobocertinib capsules) has been granted accelerated approval as an oral treatment for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test and in whom disease has progressed despite receiving chemotherapy.
 
Life Technologies’ Oncomine Dx Target Test was also approved as a companion diagnostic to identify patients with the mutations for treatment with Exkivity.
 
Exkivity’s approval was based on findings from the international, nonrandomized, open-label, multicohort Study 101 in 114 patients from the indicated population who received daily Exkivity until disease progression or intolerable toxicity. Overall response rate was 28%, with a median duration of response of 17.5 months.
 
The review used the assessment aid. The application was granted priority review and breakthrough therapy and orphan drug designations. The review was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, and the  UK’s Medicines & Healthcare products Regulatory Agency.
 
Under accelerated approval requirements, continued approval for this indication will depend on findings of clinical benefit in follow-up confirmatory trials.
 
Tivdak nabs accelerated approval for recurrent/metastatic cervical cancer
Seagen’s Tivdak (tisotumab vedotin-tftv injection) has been granted accelerated approval for treating recurrent or metastatic cervical cancer in adults whose disease has progressed despite receiving chemotherapy.
 
Approval was based on findings from the open-label, multicenter, single-arm innovaTV 204 trial in 101 patients from the indicated population who received Tivdak until disease progression or unacceptable toxicity. The objective response rate was 24%, and median duration of response was 8.3 months.
 
The review used the assessment aid, and the application was granted priority review. Under accelerated approval requirements, continued approval for this indication will depend on findings of clinical benefit in follow-up confirmatory trials.
 
Opzelura gets the green light for atopic dermatitis (AD)
Incyte’s Opzelura (ruxolitinib cream) has been approved as a short-term treatment for mild to moderate atopic dermatitis, or eczema, in patients aged 12 years or older in whom the condition is not well controlled with topical therapies.
 
The approval was based on findings from two randomized, double-blind, vehicle-controlled Phase 3 studies, TRuE-AD1 and TRuE-AD 2, in more than 1,200 patients from the indicated population. At Week 8, 53.8% and 51.3% of Opzelura patients in TRuE-AD1 and TRuE-AD2, respectively, had achieved significantly clearer skin compared with baseline measures (vehicle: 15.1% and 7.6%). Also at Week 8, 52.2% and 50.7% of Opzelura patients, respectively, experienced a reduction in itch score compared with baseline (vehicle: 15.4% and 16.3%).
 
Byooviz okayed for treating age-related macular degeneration and other eye diseases
Samsung Bioepis’s Byooviz (ranibizumab-nuna, intravitreal injection) has been approved as the first biosimilar to Lucentis (ranibizumab injection; Genentech) for treating several eye diseases and conditions, including neovascular age-related macular degeneration (nAMD), also known as “wet” AMD.
 
Approval of Byooviz was based on a review of evidence demonstrating its biosimilarity to Lucentis.
 
New indications
Cabometyx use extended to adults, adolescents with differentiated thyroid cancer
Exelixis’s Cabometyx (cabozantinib tablets) has received a new indication for treating locally advanced or metastatic differentiated thyroid cancer in adults and adolescents whose disease has progressed after VEGFR-targeted therapy and who do not qualify for, or are refractory to, radioactive iodine.
 
The approval was based on findings from the randomized, double-blind, placebo-controlled, multicenter COSMIC-311 trial. Patients from the indicated population were randomized 2:1 to receive daily Cabometyx or placebo with best supportive care until disease progression or intolerable toxicity. Primary efficacy outcome measures were progression-free survival (PFS) in the intent-to-treat population and overall response rate (ORR) in the first 100 randomized patients. Median PFS was 11.0 months in the Cabometyx group, compared with 1.9 months in the placebo group. ORR was 18% and 0%, respectively.
 
This review used the assessment aid. The application was granted priority review and breakthrough and orphan drug designations.
 
Cabometyx was first approved in 2016 and is also used to treat renal cell carcinoma and hepatocellular carcinoma.
 
Jakafi gets new indication for chronic graft-versus-host disease
Incyte’s Jakafi (ruxolitinib) has received a new indication for treating chronic graft-versus-host disease (cGVHD) in adults and patients aged 12 years or older after failure of systemic therapy.
 
The approval was based on findings from the open-label, multicenter REACH-3 trial in which 329 patients from the indicated population were randomized 1:1 to receive Jakafi or best available therapy (BAT). Overall response rates were 70% and 57% for the Jakafi and BAT groups, respectively. Median durations of response, calculated from first response to progression, death, or new systemic GVHD therapies, were 4.2 months and 2.1 months. Median times from first response to death or new systemic therapies were 25 months and 5.6 months, respectively.
 
The review  was conducted under Project Orbis in collaboration with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, Swissmedic, and the UK’s Medicines & Healthcare products Regulatory Agency.
 
The application was granted priority review and orphan product designation.
 
Jakafi was first approved in 2011 and is also used to treat myelofibrosis, polycythemia vera, and acute GVHD.

 
 

 

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Tags: FDA, US

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