FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

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

Drugs & Targets

FDA grants priority review for Ziihera in first-line HER2+ GEA

FDA has accepted for filing with Priority Review the supplemental Biologics License Application for Ziihera (zanidatamab-hrii) containing combinations for the first-line treatment of adult patients with HER2-positive unresectable locally advanced or metastatic gastric, gastroesophageal junction, or gastroesophageal adenocarcinoma.

May 01, 2026

Vol.52 No.17

Cancer Policy

One year of reducing animal testing in drug development

FDA announced that it has achieved its first-year goals in implementing its roadmap to reduce animal testing in preclinical studies.

April 24, 2026

Vol.52 No.16

By Claire Marie Porter

Cancer Policy

FDA and CMS announce RAPID coverage pathway aimed at accelerating patient access to some Breakthrough medical devices

The Centers for Medicare and Medicaid Services and FDA announced a new coverage pathway—called the Regulatory Alignment for Predictable and Immediate Device, or RAPID pathway—designed to expedite access to certain FDA-designated Class II and Class III Breakthrough devices for people with Medicare.

April 24, 2026

Vol.52 No.16

FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

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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

FDA grants priority review for Ziihera in first-line HER2+ GEA

One year of reducing animal testing in drug development

FDA and CMS announce RAPID coverage pathway aimed at accelerating patient access to some Breakthrough medical devices

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FDA grants Enhertu Breakthrough Therapy designation as post-neoadjuvant therapy for HER2+ early breast cancer

YOU MAY BE INTERESTED IN

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

FDA grants priority review for Ziihera in first-line HER2+ GEA

One year of reducing animal testing in drug development

FDA and CMS announce RAPID coverage pathway aimed at accelerating patient access to some Breakthrough medical devices

Never miss an issue!

Login

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