Breakthrough Cancer Drug Achieves Landmark FDA Approval

Promising cancer drug dostarlimab is advancing toward broader availability after receiving Breakthrough Therapy Designation from the FDA. This designation aims to expedite its development and market approval, potentially cutting years off its timeline if further testing is successful.

Dostarlimab (Jemperli), a PD-1-blocking antibody, showed groundbreaking results in clinical trials, eliminating rectal cancer tumors without surgery, radiation, or chemotherapy. This immunotherapy could transform treatment, sparing patients from life-altering side effects like incontinence and infertility.

“The 100% clinical complete response rate observed with dostarlimab highlights its potential to revolutionize care for patients with advanced dMMR/MSI-H rectal cancer,” said Hesham Abdullah, Senior Vice President at GlaxoSmithKline (GSK), emphasizing its promise to improve long-term quality of life.

FDA Breakthrough Designation Highlights Dostarlimab’s Potential Amid Rigorous Approval Process

The FDA reserves Breakthrough Therapy Designation for drugs addressing serious conditions without comparable treatments. By June 2024, only 587 of 1,516 applications had been approved, highlighting the process’s selectivity. Dostarlimab, already granted Fast Track status in January 2023, has shown extraordinary promise.

Trials at Memorial Sloan Kettering Cancer Center demonstrated its effectiveness, eliminating tumors in 42 rectal cancer patients who remain cancer-free. MSK oncologist Andrea Cercek reported mild side effects and lasting results, with some patients cancer-free for up to four years.

Dostarlimab’s 100% success rate—measured as a complete pathologic response, with no tumor evidence confirmed through MRI, endoscopy, and physical exams—could significantly accelerate its public availability. With further FDA guidance, the drug may reach the market approximately three years earlier than treatments undergoing standard approval processes.

Each year, 46,220 Americans are diagnosed with rectal cancer, 10% of which are dMMR/MSI-H cases. Dostarlimab offers hope for significantly improved outcomes in this subgroup.

Read Original Article: New Atlas

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