Regulatory Focus™ > News Articles > 2021 > 7 > FDA Approvals Roundup: Bydureon, Dalvance, Shingrix

FDA Approvals Roundup: Bydureon, Dalvance, Shingrix

Posted 28 July 2021 | By Renee Matthews 

FDA Approvals Roundup: Bydureon, Dalvance, Shingrix

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

New indications
Bydureon use extended for type 2 diabetes in adolescents
AstraZeneca’s Bydureon and Bydureon BCise (exenatide extended-release injection) have received expanded indications for improving glycemic control in children aged 10 years or older with type 2 diabetes.
 
The approval was based on effectiveness and safety findings from a 24-week, double-blind, placebo-controlled study in 82 patients from the indicated population. Patients were randomized to receive weekly exenatide extended-release or a placebo. At week 24, study group patients had an average 0.25% decrease in HbA1c, compared with an average 0.45% increase in HbA1c among placebo patients (a total average difference between groups, -0.70%).
 
The glucagon-like peptide-1 receptor agonist was first approved in 2012 for adults with type 2 diabetes.
The application was granted priority review.
 
Dalvance gets go-ahead for acute skin infections in babies, children
AbbVie’s Dalvance (dalbavancin injection) has received a new indication for treating acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. The indication covers infections caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, or MRSA.
 
Approval of Dalvance was based on findings from a multicenter, open-label, actively controlled clinical trial in the indicated population as well as 3 pharmacokinetic studies. In the clinical trial, evaluating safety and tolerability, patients were randomized 3:3:1 to receive Dalvance (single- or 2-dose) or a comparator course of intravenous vancomycin, oxacillin, or flucloxacillin, with aztreonam for Gram-negative coverage permitted in all arms. The trial was not powered for a comparative inferential efficacy analysis. The proportion of patients aged 3 months or older with an early clinical response was 97.3% in the single-dose arm, 93.6% in the 2-dose arm, and 86.7% in the comparator arm.
 
Five patients younger than 3 months were enrolled with expanded inclusion criteria and received the single-dose Dalvance regimen only. They were not included in the efficacy analyses. Safety findings for this younger patients population were similar to those seen in adults.
 
The antibiotic was originally approved in 2014 for treating ABSSSI in adults.
 
Shingrix use extended for preventing shingles in immunocompromised adults
GlaxoSmithKline’s Shingrix (zoster vaccine recombinant, adjuvanted) has been granted a new indication for prevention of shingles (herpes zoster) in patients aged 18 years or older who are vulnerable to shingles infection because of immunodeficiency or immunosuppression.
 
Shingrix is a non-live, recombinant sub-unit adjuvanted vaccine. It was originally approved in 2017 for preventing shingles in adults aged 50 years or older. Zostavax, a live attenuated virus vaccine, is also  approved for shingles in the same population.
 
Keytruda scores a new indication, moves to full approval for two more
Advanced endometrial carcinoma
Merck’s Keytruda (pembrolizumab injection), combined with Eisai’s Lenvima (Lenvatinib capsules), has received full approval for a new indication for treating advanced endometrial carcinoma that is not repair deficient in previously treated patients with disease progression who do not qualify for curative surgery or radiation.
 
The combination for this population had been granted accelerated, conditional approval in 2019.
 
The current approval was based on findings from the multicenter, open-label, randomized, active-controlled KEYNOTE-775 trial in 827 patients from the indicated population. They were randomized 1:1 to receive either the Keytruda-Lenvima combination or investigator’s choice of doxorubicin or paclitaxel.
Median progression-free survival was 6.6 months for patients in the study group, compared with 3.8 months for those receiving doxorubicin or paclitaxel. Median overall survival was 17.4 months and 12.0 months, respectively. Overall response rate was 30% and 15%, and median duration of response was  9.2 months and 5.7 months.
 
The review used the assessment aid, and the application was granted priority review. The Keytruda-Lenvima combination received breakthrough therapy designation for this indication.
 
Keytruda  was first approved in 2014  for treating melanoma in adults and is used to treat several other types of cancers.
 
Triple-negative breast cancer
Keytruda also received a new indication, in combination with chemotherapy, as a neoadjuvant treatment for high-risk, early-stage, triple-negative breast cancer (TNBC) that is continued as a single-agent adjuvant treatment after surgery.
 
In addition, the agency granted regular approval to the Keytruda-chemotherapy combination for patients with locally recurrent unresectable or metastatic TNBC whose tumors express programmed death-ligand 1. It had granted accelerated approval this indication in November 2020.
 
Approval for the neoadjuvant and adjuvant indication was based on efficacy findings from the randomized, multicenter, double-blind, placebo-controlled KEYNOTE-522 trial conducted in 1,174 patients from the indicated population. They were randomized to receive the Keytruda-chemotherapy combination or chemotherapy alone. The main efficacy outcome measures were pathological complete response (pCR) rate and event-free survival (EFS). The pCR rate was 63% for patients receiving the study combination, compared with 56% for patients who received chemotherapy alone. In all 123 and 93 patients, respectively, experienced EFS.
 
This review used the real-time oncology review pilot program and the assessment aid. The application was granted priority review. Keytruda received breakthrough therapy designation for this indication.
 

 

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Tags: FDA, US

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