EU Adds CAR-T Warning; New Blincyto Indication; Good News in Pancreatic Cancer

Following the FDA’s lead, the European Medicines Agency will require labeling for CAR T-cell therapies to include a notice about a risk of second malignancies and that patients receiving the therapies should be monitored for life. (Reuters)

The Supreme Court agreed to hear arguments in a lawsuit by more than 200 hospitals, alleging that Medicare underpays facilities that serve low-income populations. (Reuters)

AstraZeneca announced that a phase III trial of capivasertib (Truqap) plus paclitaxel failed to improve overall survival versus paclitaxel plus placebo in unresectable/metastatic triple-negative breast cancer with specific types of mutations.

Amgen announced that the FDA expanded indications for blinatumomab (Blincyto) to include consolidation therapy for children and adults with B-cell precursor acute lymphoblastic leukemia.

The FDA has placed a partial hold on an early-stage clinical study of a BioNTech antibody-drug conjugate being evaluated in patients with previously treated lung and breast cancers because of a concern about an unreasonable risk of illness or injury at higher doses. (Reuters)

The agency also placed a hold on three clinical studies of the WEE1 inhibitor azenosertib in patients with solid tumors, following two suspected sepsis-related deaths in one of the trials, Zentalis Pharmaceuticals announced.

Patients who received the anti-inflammatory celecoxib after surgery for PIK3CA-mutated colon cancer had improved overall and disease-free survival. (Journal of Clinical Oncology)

Serial measurement of immunoglobulin G was associated with a significantly lower rate of infection in chronic lymphocytic leukemia and non-Hodgkin lymphoma. (Blood Advances)

Preoperative treatment with an investigational leukocyte interleukin injection (dubbed Multikine) was associated with a significant improvement in survival for patients with head and neck cancer and low levels of PD-L1 expression, CEL-SCI announced.

Neoadjuvant and adjuvant chemotherapy for pancreatic cancer led to better survival than would have been expected with adjuvant therapy only. (JAMA Oncology)

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