Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized controlled trials are not feasible due to small patient populations.

February 27, 2026

Vol.52 No.08

Clinical Roundup

Follicular lymphoma may be curable with chemoimmunotherapy combo, data from 15-year trial suggests

Long-term data on patients treated with a standard chemoimmunotherapy combination show relapse rates dropped over time and 70% of patients were still alive 15 years later, with an overall cure rate estimated at 42% of patients treated, according to a study led by scientists at SWOG, Fred Hutch Cancer Center, and the University of Rochester Medical Center.

February 27, 2026

Vol.52 No.08

Drugs & Targets

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

FDA granted full approval to Braftovi (encorafenib) in combination with cetuximab (Erbitux) and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation based on results from the global phase III BREAKWATER trial.

February 27, 2026

Vol.52 No.08

Drugs & Targets

FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC

FDA approved Hernexeos (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

February 27, 2026

Vol.52 No.08

Cancer Policy

At Friends meeting, Pazdur, Woodcock lament FDA’s failure to protect the agency staff from political interference, warn of “lasting implications”

For decades, FDA commissioners sought to insulate the agency’s professional staff from political interference with regulatory decisions.

February 20, 2026

Vol.52 No.07

By Jacquelyn Cobb and Claire Marie Porter

Cancer Policy

Bayer agrees to $7.25B settlement over lawsuits alleging Roundup weedkiller caused cancer

Bayer, the owner of the herbicide Roundup, offered $7.25 billion to settle thousands of lawsuits alleging that the product is responsible for causing cases of Non-Hodgkin lymphoma.

February 20, 2026

Vol.52 No.07

By Sara Willa Ernst

Improving on R-CHOP, ODAC votes 11:2 to move Genentech’s Polivy to the first line in diffuse large B-cell lymphoma

YOU MAY BE INTERESTED IN

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

Follicular lymphoma may be curable with chemoimmunotherapy combo, data from 15-year trial suggests

FDA approves Braftovi combination regimen in first-line metastatic colorectal cancer

FDA approves Hernexeos as an initial treatment for HER2-mutant advanced NSCLC

At Friends meeting, Pazdur, Woodcock lament FDA’s failure to protect the agency staff from political interference, warn of “lasting implications”

Bayer agrees to $7.25B settlement over lawsuits alleging Roundup weedkiller caused cancer

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