FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

FDA approved Tuksya (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. The approval expands the use of Tuksya to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

October 09, 2026

Vol.52 No.37

Regulatory News

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

Nearly two years after FDA issued a final rule requiring radiologists to tell women whether their breasts are “dense” or “not dense” after a mammogram, the notification has become nearly universal.

October 02, 2026

Vol.52 No.36

By Claire Marie Porter

Clinical Regulatory News

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”

For the past four decades, psilocybin research has focused on one area: the treatment of mental health disorders, including depression, anxiety, existential distress associated with serious medical illnesses, post-traumatic stress disorder, and addiction.

City of Hope’s “plug-and-play” CAR T platform lets researchers update cells after infusion

Researchers from City of Hope have developed a “plug-and-play” technology that adds engineered molecules to chimeric antigen receptor T cells after treatment, allowing scientists to better control the cells and redirect them to attack different types of cancer. The preclinical study offers a more flexible way to help CAR T cells keep pace with mutating tumors.

October 02, 2026

Vol.52 No.36

Clinical Roundup

Mount Sinai-led study identifies why some patients develop severe intestinal inflammation after CAR T therapy

Researchers at the Icahn School of Medicine at Mount Sinai have identified biological mechanisms that may contribute to CAR T-cell-associated enterocolitis, a serious inflammatory condition of the intestine that can occur after a type of CAR T cell therapy for multiple myeloma.

October 02, 2026

Vol.52 No.36

Drugs & Targets

FDA approves Degevma, a biosimilar for cancer-related bone complications

FDA approved Degevma (denosumab-adet) as a biosimilar to Xgeva (denosumab).

October 02, 2026

Vol.52 No.36

FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

YOU MAY BE INTERESTED IN

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”

City of Hope’s “plug-and-play” CAR T platform lets researchers update cells after infusion

Mount Sinai-led study identifies why some patients develop severe intestinal inflammation after CAR T therapy

FDA approves Degevma, a biosimilar for cancer-related bone complications

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FDA tells sponsors of CAR T-cell therapies to add boxed warning about secondary T-cell malignancies

YOU MAY BE INTERESTED IN

FDA approves tucatinib + trastuzumab + pertuzumab for maintenance treatment of HER2+ breast cancer

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

City of Hope’s “plug-and-play” CAR T platform lets researchers update cells after infusion

Mount Sinai-led study identifies why some patients develop severe intestinal inflammation after CAR T therapy

FDA approves Degevma, a biosimilar for cancer-related bone complications

Never miss an issue!

Login

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”