FDA approval of IDE supplement to expand Alpha DaRT IMPACT Trial to patients with pancreatic cancer receiving gemcitabine with abraxane

Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC

AstraZeneca’s application for camizestrant, a next-generation oral selective estrogen receptor degrader, or SERD, in metastatic breast cancer might have seemed set to sail smoothly through the FDA approval process.

Electric jolt technique offers possible avenue for early detection of pancreatic cancer, OHSU-led study finds

Scientists at Oregon Health & Science University have developed a technique using an electronic jolt and nanoparticles to reveal the telltale signal of an insidious form of cancer. The technique offers a new way to detect early signs of pancreatic cancer—a particularly deadly type of cancer because it isn’t detected until it’s progressed to later stages that are difficult to treat effectively. The new method would involve a simple blood draw among people who are considered higher risk due to family history or other factors.

May 08, 2026

Vol.52 No.18

Drugs & Targets

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA has issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol for its experimental pancreatic cancer drug, daraxonrasib, a RAS inhibitor.

May 08, 2026

Vol.52 No.18

By Claire Marie Porter

Regulatory News

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

Disappointment hangs in the air as Replimune’s Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab in the treatment of advanced melanoma was denied again by FDA on April 10.

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

The FDA Oncologic Drugs Advisory Committee on April 30 considered two applications from AstraZeneca Pharmaceuticals LP.

FDA accepts NDA for zipalertinib for NSCLC with mutations

FDA has accepted a New Drug Application for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act target action date is Feb. 27, 2027.

May 01, 2026

Vol.52 No.17

FDA approval of IDE supplement to expand Alpha DaRT IMPACT Trial to patients with pancreatic cancer receiving gemcitabine with abraxane

YOU MAY BE INTERESTED IN

Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC

Electric jolt technique offers possible avenue for early detection of pancreatic cancer, OHSU-led study finds

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA accepts NDA for zipalertinib for NSCLC with mutations

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FDA approval of IDE supplement to expand Alpha DaRT IMPACT Trial to patients with pancreatic cancer receiving gemcitabine with abraxane

YOU MAY BE INTERESTED IN

Breakthrough Therapy designation, ASCO plenary, and NEJM publication notwithstanding, breast cancer drug camizestrant gets a No from ODAC

Electric jolt technique offers possible avenue for early detection of pancreatic cancer, OHSU-led study finds

FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients“Patients are owed another review.”

ODAC recommends against approval of camizestrant NDA, gives a nod to sNDA for capivasertib

FDA accepts NDA for zipalertinib for NSCLC with mutations

Never miss an issue!

Login

FDA’s second rejection of Replimune’s melanoma treatment stirs worry among oncologists, patients
“Patients are owed another review.”