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Posted 11 May 2022 | By Renee Matthews 

FDA Approvals Roundup: Olumiant, Enhertu

2936 A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
 
New indications
Olumiant use extended for hospitalized COVID-19 patients needing oxygen support
Eli Lilly’s Olumiant (baricitinib tablets) has been granted a new indication for treating COVID-19 in hospitalized adults who require varying degrees of ventilation/oxygen support.
 
Olumiant has been available to treat COVID-19 in the US under emergency use authorization (EUA) since November 2020. The EUA will remain in place for hospitalized pediatric patients aged 2 to less than 18 years old who require oxygen support.
 
This latest supplemental approval for Olumiant, a JAK inhibitor, was based on findings from two Phase 3 randomized, double-blind, placebo-controlled studies, ACTT-2 and COV-BARRIER, and the COV-BARRIER OS 7 addendum study.
 
In ACTT-2, 1,033 patients from the indicated population were randomized 1:1 to receive daily Olumiant plus remdesivir or placebo plus remdesivir for 14 or 10 days, respectively, or until discharge. Median time to recovery was 7 days for the study group patients and 8 days for the placebo group. Study group patients were more likely to have a better clinical status at day 15 than their placebo counterparts. By day 29, 23% of study group patients had died or progressed to oxygen support, compared with 28% of placebo patients, and 4.7% and 7.1%, respectively, had died.
 
COV-BARRIER compared Olumiant with placebo in 1,525 patients. In all, 27.8% of Olumiant patients died or progressed to oxygen support within the first 28 days of the study, compared with 30.5% of placebo patients, but the effect was not statistically significant (odds ratio, 0.85; P = .180). By day 28, 8.1% of Olumiant patients had died, compared with 13.3% of placebo patients.
 
The COV-BARRIER OS 7 addendum study included 101 COV-BARRIER patients who required invasive mechanical ventilation or extracorporeal membrane oxygenation at baseline. They were randomized 1:1 to received standard of care plus either Olumiant or placebo for 14 days or until hospital discharge. A prespecified exploratory analysis showed that, by day 28, 39.2% of Olumiant patients had died, compared with 58.0% of placebo patients.
 
 
The drug comes with a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
 
Olumiant was discovered by Incyte and licensed to Lilly. It was originally approved in 2018 for treating adults with moderately to severely active rheumatoid arthritis with inadequate response to tumor necrosis factor antagonist therapies.
 
Enhertu nabs new indication for advanced, recurrent HER2-positive breast cancer
Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki injection) has received a new indication for treating unresectable or metastatic HER2-positive breast cancer in adults who have received a previous anti-HER2-based regimen in the metastatic, neoadjuvant, or adjuvant setting and whose disease recurred within 6 months of completing therapy.
 
The HER2-directed antibody and topoisomerase inhibitor conjugate was granted accelerated approval in December 2019 for treating unresectable or metastatic HER2-positive breast cancer in adults who have received two or more anti-HER2-based regimens in the metastatic setting.
 
This latest supplemental approval was supported by findings from the multicenter, open-label, DESTINY-Breast03 trial in 524 patients from the indicated population who were randomized 1:1 to receive Enhertu or ado-trastuzumab emtansine until unacceptable toxicity or disease progression.
 
Median progression-free survival (PFS), the primary endpoint, was not reached in the Enhertu arm and was 6.8 months in the ado-trastuzumab emtansine arm. At the time of the PFS analysis, 16% of patients had died and overall survival was immature. The objective response rate was 82.7% in the Enhertu arm and 36.1% in the ado-trastuzumab emtansine arm.
 
This review was conducted under Project Orbis in collaboration with Australian Therapeutic Goods Administration, Health Canada, Israel’s Ministry of Health Pharmaceutical Administration, and Swissmedic.
 
The FDA review used the real-time oncology review pilot program and the Assessment Aid. The application was granted priority review and breakthrough and orphan drug designations.
 
Enhertu comes with a boxed warning for interstitial lung disease and embryo-fetal toxicity.
 
 

 

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Tags: FDA, US

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