FDA Approvals Roundup: Ebanga, Margenza, Orgovyx

RoundupsRoundupsRegulatory NewsRegulatory News | 23 December 2020 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

New approvals
Ebanga wins approval for treating Zaire Ebolavirus in adults and children
Ridgeback Biotherapeutics’ Ebanga (Ansuvimab-zykl) has been approved for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children, making it the second approval for the virus since  Regeneron’s antibody cocktail, Inmazeb, was greenlighted in October.
Ebanga’s safety and efficacy were evaluated in the PALM trial in 2018-2019 during an Ebola outbreak in the Democratic Republic of the Congo. The multicenter, open-label, randomized, controlled trial included 174 patients (120 adults, 54 children) in patients with confirmed Ebolavirus infection who received Ebanga and 168 infected participants (135 adults, 33 children ) who received a control. Primary efficacy endpoint was 28-day mortality. After 28 days, 35.1% of patients receiving Ebanga had died, compared with 49.4% of those receiving a control.
Ebanga is a human monoclonal antibody that acts by blocking the virus from binding to the cell receptor and preventing it from entering the cell. The Zaire ebolavirus is one of four Ebolavirus species that can cause the disease.
The drug was granted orphan drug and breakthrough therapy designations.
Margenza gets the go-ahead for metastatic, HER2-positive breast cancer
MacroGenics’ Margenza (margetuximab-cmkb) has been approved, in combination with chemotherapy, for treating metastatic HER2-positive breast cancer in adults who have received two or more previous anti-HER2 regimens, of which at least one was for metastatic disease.
Efficacy of the monoclonal antibody was evaluated in the randomized, multicenter, open-label SOPHIA study with 536 previously treated patients from the indicated population. They were randomized 1:1 to receive Margenza plus chemotherapy or Herceptin (trastuzumab) plus chemotherapy. Patients receiving Margenza had a median progression-free survival of 5.8 months, compared with 4.9 months in controls. Confirmed objective response rate was 22% versus 16%, respectively, and duration of response, 6.1 months versus 6.0 months, respectively.
The review used the assessment aid. The application was granted fast-track designation.
Orgovyx okayed as first GnRH receptor antagonist for advanced prostate cancer
Myovant’s Orgovyx (relugolix) has received approval as the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist for treating adults with advanced prostate cancer.
Efficacy was evaluated in 934 men in the randomized, open-label HERO trial who were randomized 2:1  to receive Orgovyx or leuprolide acetate. The main efficacy outcome measure was medical castration by day 29 through 48 weeks of treatment. The rate was 96.7% in the Orgovyx arm.
The review used the assessment aid, and the application was granted priority review.
Riabni approved as third biosimilar for Rituxan
Amgen’s Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab), has been approved as a therapy for  adults with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).
Findings from a randomized, double-blind, comparative clinical study with 256 patients showed Riabni, a CD20-directed cytolytic antibody, was highly similar to its Rituxan reference product in terms of efficacy and safety profiles. Patients were randomized 1:1 to receive either Riabni or Rituxan weekly for 4 weeks, then at 12 and 20 weeks. An assessment of the overall response rate (ORR) by week 28, was within the prespecified margin for Riabni compared with Rituxan, showing clinical equivalence.
The list price of Riabni in the US will be 23.7% lower than Rituxan, and at its launch, the biosimilar’s average selling price will be 16.7% below that of Rituxan.
New indications
Tagrisso picks up new indication for early-stage lung cancer
AstraZeneca’s Tagrisso (osimertinib) has been approved as the first adjuvant treatment for patients with non‒small cell lung cancer (NSCLC) with a specific type of genetic mutation.
The drug was approved in 2018 for the first-line treatment of metastatic non-small cell lung cancer in patients with tumors with EGFR exon 19 deletions or exon 21 L858R mutations.
For the current approval, Tagrisso was evaluated in a randomized, double-blind, placebo-controlled trial of 682 patients with early stage non-small cell lung cancer and the aforementioned mutations. Patients receiving Tagrisso had an 80% decrease in chance of disease recurrence compared with patients receiving placebo.
Tagrisso received orphan drug designation for treatment of EGFR mutation-positive non-small cell lung cancer and was granted a breakthrough therapy designation for this indication. The review was conducted under Project Orbis, in collaboration with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, Singapore’s Health Sciences Authority, and Swissmedic.
Xpovio handed extended indication for refractory/relapsed multiple myeloma
Karyopharm’s  Xpovio (selinexor) has been approved in combination with bortezomib and dexamethasone as a therapy for previously treated adults with refractory or relapsed multiple myeloma (RRMM).
The drug received accelerated approval in 2019 in combination with dexamethasone for use in previously treated adults with RRMM.
The efficacy of Xpovio combined with bortezomib and dexamethasone was evaluated in the randomized, open-label, multicenter, active comparator-controlled BOSTON trial in patients from the indicated population. They received Xpovio in combination with bortezomib and dexamethasone or  bortezomib plus dexamethasone alone. Estimated median PFS was 13.9 months for patients in the study combination arm and 9.5 months for the control arm.
The application underwent regular review and received orphan drug designation.
Xeomin gains expanded indication for treating chronic drooling in children
Merz Therapeutics’ Xeomin (incobotulinumtoxinA) has been approved as a therapy for chronic drooling in neurologically impaired children aged 2 years or older. It is the only neuromodulator approved for this indication in the US.
The approval was based on safety and efficacy findings from a phase 3 prospective, randomized, double-blind, placebo-controlled, multicenter study in 255 children and adolescents aged 2-17 years. Patients receiving Xeomin had significantly reduced unstimulated Salivary Flow Rate over 64 weeks compared with patients who received placebo. The safety findings were similar to those in previous adult and pediatric studies.
Xeomin has previous approvals for use in adults with cervical dystonia and blepharospasm, glabellar lines, upper limb spasticity, and excessive drooling.
The supplemental biologics license application was granted a priority review designation. The drug was granted an orphan drug designation and granted a breakthrough therapy designation.


© 2022 Regulatory Affairs Professionals Society.

Tags: FDA, US

Discover more of what matters to you

No taxonomy