FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM

FDA has approved teclistamab (Tecvayli) in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

March 06, 2026

Vol.52 No.09

Drugs & Targets

FDA grants tentative approval for Lutetium Lu 177 dotatate

FDA has granted tentative approval for the Abbreviated New Drug Application for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent version of Lutathera (lutetium Lu 177 dotatate), which is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.

March 06, 2026

Vol.52 No.09

Cancer Policy

FDA issues draft guidance on accelerating development of individualized therapies for ultra-rare diseases

FDA issued draft guidance for sponsors seeking full approval for targeted individualized therapies by generating substantial evidence of effectiveness and safety when randomized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

Rybrevant Faspro + immunotherapy shows strong clinical benefit for recurrent or metastatic head-and-neck cancer

Data from the phase Ib/II OrigAMI-4 study found that first-line treatment with investigational subcutaneous amivantamab and hyaluronidase-lpuj in combination with a PD-1 inhibitor delivered clinically meaningful and durable antitumor activity in patients with head and neck squamous cell carcinoma that is recurrent or metastatic, PD-L1-positive, and HPV-unrelated.

February 27, 2026

Vol.52 No.08

Clinical Roundup

Adjuvant immunotherapy + hormone therapy may counteract immune-suppression in early-stage prostate cancer, Mayo-led study finds

Pairing a next-generation immunotherapy with standard hormone therapy before surgery may help overcome a long-standing barrier in early-stage prostate cancer treatment, according to a Mayo Clinic-led study.

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

FDA investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous CAR T-cell immunotherapies

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FDA approves teclistamab + daratumumab hyaluronidase-fihj for r/r MM

FDA grants tentative approval for Lutetium Lu 177 dotatate

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

Rybrevant Faspro + immunotherapy shows strong clinical benefit for recurrent or metastatic head-and-neck cancer

Adjuvant immunotherapy + hormone therapy may counteract immune-suppression in early-stage prostate cancer, Mayo-led study finds

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

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