FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer

Neoadjuvant dostarlimab averts brutal surgery in 80% of patients with dMMR solid tumors

Three years ago, researchers from Memorial Sloan Kettering Cancer Center published stunning results: For the 5% of rectal cancer patients whose tumors are mismatch-repair deficient, neoadjuvant dostarlimab-gxly (Jemperli) has the makings of a silver bullet.

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

When Kelly Spill was eight months pregnant, she experienced some constipation and noticed blood in her stool. Her OBGYN wasn’t worried.

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

A novel combination therapy offers better outcomes for patients with KRAS G12C metastatic colorectal cancer that have stopped responding to chemotherapy, according to a phase III clinical trial by researchers at City of Hope.

May 02, 2025

Vol.51 No.17

Regulatory News

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.

April 25, 2025

Vol.51 No.16

By Claire Marie Porter

Cancer Policy

ASCO seeks to engage new leaders of NIH, CMS, and FDA

The Association for Clinical Oncology has reached out to the new leaders of federal health agencies to ensure continued progress in cancer care, research, and patient access, the organization said.

FDA’s Richard Pazdur to receive the 2025 AACR Enduring Impact Award for transformative service to cancer science and medicine

The 2025 AACR Enduring Impact Award for Transformative Service to Cancer Science and Medicine will be presented to FDA’s Richard Pazdur during the AACR Annual Meeting 2025, to be held April 25-30 at the McCormick Place Convention Center in Chicago.

April 25, 2025

Vol.51 No.16

FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer

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Neoadjuvant dostarlimab averts brutal surgery in 80% of patients with dMMR solid tumors

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

ASCO seeks to engage new leaders of NIH, CMS, and FDA

FDA’s Richard Pazdur to receive the 2025 AACR Enduring Impact Award for transformative service to cancer science and medicine

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FDA grants regular approval to dostarlimab-gxly for dMMR endometrial cancer

YOU MAY BE INTERESTED IN

Neoadjuvant dostarlimab averts brutal surgery in 80% of patients with dMMR solid tumors

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertileSix years later, she is well—and pregnant with her third child

Sotorasib + panitumumab offers better outcomes in colorectal cancer that no longer responds to treatment

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industryCommissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas

ASCO seeks to engage new leaders of NIH, CMS, and FDA

FDA’s Richard Pazdur to receive the 2025 AACR Enduring Impact Award for transformative service to cancer science and medicine

Never miss an issue!

Login

Kelly Spill opted for dostarlimab trial, avoiding rectal cancer treatment that would leave her infertile
Six years later, she is well—and pregnant with her third child

Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industry
Commissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas