April 2023 Brief

Soon, the FDA will be considering fruquintinib for approval to treat patients with refractory metastatic colorectal cancer.

Enfortumab vedotin plus pembrolizumab is now an FDA approved treatment based on positive phase 1b/2 findings.

Results from the phase 2 PHAROS trial of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic non–small cell lung cancer has led the FDA to accept supplemental new drug applications for the agents. Further data will be presented at an upcoming medical meeting.

Multiple trials and techniques have evaluated treatment with HLX02 compared with trastuzumab. Now, the FDA has accepted the biologics license application HLX02 for patients with HER2-overexpressing metastatic breast cancer, breast cancer, gastric cancer, and gastroesophageal junction adenocarcinoma.

The investigational new drug, SynKIR-110, has received a fast track designation from the FDA for patients with mesothelioma and is continuing to be evaluated in a phase 1 trial.

CB-011 has received a fast track designation from the FDA for the treatment of relapsed/refractory multiple myeloma and is being investigated in the ongoing CaMMouflage study.

TP-1287, an investigational oral phosphate prodrug of the CDK9 inhibitor alvocidib, has been granted an orphan drug designation by the FDA for patients with Ewing sarcoma.

Multiple cases of unacceptable toxicity requiring dose reductions have occurred in a phase 1 study of MT-0169 in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma. The FDA has placed a partial clinical hold on the study

KEYNOTE-859 findings are under review by the FDA as the regulatory body considers an approval application for pembrolizumab plus chemotherapy for the treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA has now granted OM-301 2 orphan drug designations for the treatment of patients with multiple myeloma and acute myeloid leukemia.

The FDA has requested positive results from a second clinical study of SGX301 in patients with early stage cutaneous T-cell lymphoma before filing a new drug application.

Omidubicel showed encouraging clinical benefit in a phase 3 study vs standard myeloablative umbilical cord blood in patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. Now, the FDA has approved the agent for this indication.

The FDA plans to conduct a speedy review of an approval application for trifluridine plus tipiracil and bevacizumab for the treatment of metastatic colorectal cancer.

The combination of botensilimab and balstilimab is moving down the FDA pipeline and may become an approved treatment for non-microsatellite instability-high and deficient mismatch repair metastatic colorectal cancer in the future.

On the heels of a positive ODAC vote, polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone is now FDA-approved.

The new Prescription Drug User Fee Act action date for quizartinib for use in patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia has been set to July 24, 2023.

Promising results from a type C meeting with the FDA has led to a phase 2/3 trial of darovasertib and crizotinib being initiated in 2023 for patients with first-line HLA-A2 negative metastatic uveal melanoma.

The FDA continues to push forward PSMA-targeted therapies to address unmet needs for patients with metastatic castration-resistant prostate cancer.

A patient treated with the second highest dose level of FHD-609 had a grade 4 adverse event. Enrollment in the study of the agent in patients with synovial sarcoma or SMARCB-1 deleted tumors has been halted.

The Oncologic Drugs Advisory Committee has discussed the approval application for olaparib plus abiraterone and prednisone or prednisolone for patients with metastatic castration-resistant prostate cancer and voted on its potential future.