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FDA Grants Accelerated Approval to GSK’s dMMR Antibody Drug

Other recent FDA approvals include Eli Lilly’s Jardiance to reduce the risk of cardiovascular death for adults with heart failure and Roche’s companion diagnostic test to identify solid tumors.

By
  • Samantha McGrail
Published: 24 Aug 2021

FDA recently granted accelerated approval to GSK’s PD-1 blocking antibody drug, Jemperli, for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors.

Specifically, the treatment is intended for individuals with dMMR who have no satisfactory alternative treatment options. 

“For patients with tumors expressing the dMMR biomarker, there continues to be a significant need for new and effective treatments,” Hal Barron, chief scientific officer and president of research and development at GSK, said in the announcement.

FDA based its approval on tumor response rate and durability of response from the dMMR endometrial cancer cohort A1 and the dMMR solid-tumor cohort F of the ongoing Garnet trial. 

The open-label study included patients with dMMR recurrent or advanced non-endometrial cancers, with the highest prevalence in colorectal, small intestine, and stomach cancers.

In the trial, patients were randomized to receive 500 milligrams of Jemperli as an intravenous infusion once every three weeks for four doses, followed by 1,000 milligrams once every six weeks until disease progression or unacceptable toxicity. 

Jemperli elicited an overall response rate of 41.6 percent with a complete response rate of 9.1 percent and a partial response rate of 32.5 percent. The median duration of response was 34.7 months. 

About 95.4 percent of patients maintained a response for six months or longer.

“Jemperli is an important new treatment option for patients with mismatch repair-deficient recurrent or advanced solid cancers who have progressed and have no alternative options,” said Jubilee Brown, MD, professor and division director of gynecologic oncology at Atrium Health Levine Cancer Institute and investigator on the Garnet study.

“As we saw in the Garnet trial, of those patients who respond to treatment with Jemperli, nearly all continued to respond for six months or longer,” Brown concluded. 

FDA Approves Eli Lilly’s Jardiance for Heart Failure Complications  

Eli Lilly and Company recently announced that FDA approved its drug, Jardiance, to reduce the risk of cardiovascular death plus hospitalization for adults with heart failure with reduced ejection fraction. 

The agency approved Jardiance 10 milligrams based on results from the Emperor-Reduced Phase 3 trial.

Researchers investigated the effect of adding Jardiance 10 milligrams versus placebo to the standard of care in 3,730 adults with and without type 2 diabetes who had heart failure and left ventricular ejection fraction of 40 percent or less.  

In the trial, Jardiance significantly reduced the risk of the primary composite endpoint of time to cardiovascular death or hospitalization for heart failure by 25 percent versus placebo. 

The drug also substantially reduced the relative risk of first and recurrent hospitalization for heart failure by 30 percent. 

“Today’s approval is significant for the millions of people diagnosed with this form of heart failure, offering additional hope for those who have seen limited new treatment options over the last decade,” Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly and Company, said in the announcement. 

“We’re excited to build on a legacy with this new indication that establishes Jardiance as an effective treatment for adults with heart failure with reduced ejection fraction – regardless of whether they have type 2 diabetes,” Emmick concluded. 

FDA OKs Roche’s Companion Diagnostic for Solid Tumors 

FDA recently approved Roche’s Ventana MMR RxDx Panel, the first companion diagnostic test to help identify patients whose solid tumors are deficient in DNA mismatch repair (MMR).

The Ventana MMR RxDx Panel is a label expansion of Roche’s current on-market Ventana MMR IHC Panel.

The newly approved test evaluates a panel of MMR proteins in tumors to help identify patients most likely to benefit from specific and targeted therapies, including GSK’s Jemperli monotherapy. 

“As the first companion diagnostic of its kind, this test can help qualify patients with solid tumors that are deficient in MMR who have progressed in their disease and who have no other suitable treatment options,” Thomas Schinecker, CEO of Roche Diagnostics, said in the announcement. 

“Based on the results of our MMR biomarker test, these patients may be eligible to receive GSK’s Jemperli. We are pleased that our innovative companion diagnostic label continues to grow to serve more patients,” Schinecker continued. 

MMR is a naturally occurring mechanism that scans DNA and corrects errors that cause disease. When MMR is deficient, cells mutate, which can lead to cancer. 

The FDA’s approval of the Ventana MMR RxDx Panel provides clinicians with access to a fully automated panel of MMR biomarkers tested by immunohistochemistry, enabling more educated treatment decisions for patients and their families.  

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