Regulatory Focus™ > News Articles > 2021 > 7 > FDA Approvals Roundup: Kerendia, Padcev, Darzalex Faspro

FDA Approvals Roundup: Kerendia, Padcev, Darzalex Faspro

Posted 14 July 2021 | By Renee Matthews 

FDA Approvals Roundup: Kerendia, Padcev, Darzalex Faspro

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New approvals
Kerendia cleared for slowing serious kidney, heart complications in type 2 diabetes
Bayer’s Kerendia (finerenone tablets) has been approved for reducing the risk of kidney function decline, kidney failure, cardiovascular death, nonfatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes.
 
Kerendia is a non-steroidal mineralocorticoid receptor antagonist. It works by blocking overactivation of the mineralocorticoid receptor, a driver of fibrosis and inflammation, which can contribute to permanent kidney damage.
 
Approval of Kerendia was based on efficacy findings from the randomized, multicenter, double-blind, placebo-controlled FIDELIO-DKD study in 5,674 patients from the indicated population. Participants were randomized to receive Kerendia or placebo and followed until their disease progressed to a composite endpoint that included at least a 40% reduction in kidney function, progression to kidney failure, or kidney death. Of the 2,833 patients receiving the study drug, 504 had at least one of the events in the composite endpoint, compared with 600 of the 2,841 placebo patients.
 
The study also compared the two groups for the number of patients experiencing cardiovascular death, a nonfatal heart attack or stroke, or hospitalization for heart failure. In that analysis, 367 of the Kerendia patients had at least one of the events included in the composite endpoint, compared with 420 of the placebo patients. Kerendia received priority review and fast track designations for the application.
 
New indications
Padcev nabs regular approval, label expansion for urothelial cancer
Astellas’ Padcev (enfortumab vedotin-ejfv IV injection) has been granted full approval and an expanded indication for treating locally advanced or metastatic urothelial cancer in previously treated adults with a programmed death receptor-1 (PD-1) or death-ligand (PD-L1) inhibitor and platinum-containing chemotherapy or who have received one or two lines of therapy but do not qualify for cisplatin-containing chemotherapy.
 
Padcev originally received accelerated approval in 2019 for patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
 
The current approval was based on findings from the open-label, randomized, multicenter EV-301 trial, which was required to confirm the clinical benefit of the 2019 approval. The 608 participants from the indicated population were randomized 1:1 to receive Padcev or investigator’s choice of single-agent chemotherapy (docetaxel, paclitaxel, or vinflunine). The primary endpoint was overall survival (OS), with progression-free survival (PFS) and overall response rate (ORR) earmarked as secondary endpoints.
 
Median OS was 12.9 months for the 301 patients receiving Padcev, compared with 9.0 months for 307 receiving chemotherapy. Median PFS was 5.6 months, compared with 3.7 months, respectively; ORR was 40.6% and 17.9%.
 
Findings from Cohort 2 of the EV-201 single-arm, multicohort, international trial formed the basis of the approval for use in patients who are ineligible for cisplatin-containing chemotherapy. It included 89 patients with locally advanced or metastatic urothelial cancer who received a prior PD-1 or PD-L1 inhibitor and were ineligible for cisplatin-containing chemotherapy. The confirmed ORR was 51%, of which 22% were complete responses. Median response duration was 13.8 months.
 
The review was conducted under Project Orbis in collaborated with Health Canada and Australia’s Therapeutic Goods Administration. It used the real-time oncology review pilot program and the assessment aid. The application was granted priority review and breakthrough therapy designation.
 
Darzalex Faspro expanded for use as combo therapy in multiple myeloma
Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj subcutaneous injection), combined with pomalidomide and dexamethasone (Pd), has been granted an extended indication for adults with multiple myeloma who have received at least one line of previous therapy.
 
Approval of Darzalex Faspro was based on findings from the open-label, active-controlled APOLLO trial
that enrolled 304 patients from the indicated population. They were randomized 1:1 to Darzalex Faspro combined with Pd, or Pd alone, and were followed until disease progression or unacceptable toxicity. The main efficacy outcome measure was progression-free survival (PFS). Median PFS was 12.4 months in the Darzalex Faspro-Pd treatment group and 6.9 months in the Pd treatment group, marking a 37% reduction in the risk of disease progression or death for patients treated with study drug combination compared with Pd alone.
 
The review used the assessment aid.
 
ArmonAir RespiClick use expanded to children younger than 12 years
Teva’s ArmonAir RespiClick (fluticasone propionate inhalation powder) has been granted an extended approval as a maintenance treatment of asthma as prophylactic therapy in children aged 4 to 11 years.
 
Approval for this younger population was based on findings from a multicenter, randomized, double-blind, placebo-controlled trial (Trial 3) in 841 children randomized 1:1 to the study drug (30 or 55 mcg) or placebo. The predefined endpoint was change from baseline in weekly average trough percent predicted forced expiratory volume in one second (ppFEV1) at 12 weeks. Estimated mean differences between the 30- and 55-mcg doses compared with placebo were 6.0% and 7.0% predicted, respectively.
 
Teva’s inhaled corticosteroid product  was originally approved in 2017 for adolescent and adult patients with asthma.
 

 

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Tags: FDA, US

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