April 2024 Brief

The biologics license application from the FDA is supported by data from the phase 3 TROPION-Breast01 trial of datopotamab deruxtecan in HR-positive, HER2-negative breast cancer.

A biologics license application for zanidatamab is being reviewed by the FDA for treating previously treated, HER2-positive biliary tract cancer.

The FDA granted a fast track designation to olaptesed pegol with bevacizumab and radiotherapy for patients with newly diagnosed glioblastoma that is resistant to chemotherapy and where measurable tumor remains after surgery.

An investigational new drug application for SynKIR-310's phase 1 trial targeting relapsed/refractory B-cell non-Hodgkin lymphomas was submitted to the FDA.

Fam-trastuzumab deruxtecan-nxki received accelerated approval from the FDA for adult patients with unresectable or metastatic HER2-positive solid tumors.

SH-201 is a new, promising option for certain types of leukemias, including chronic myeloid leukemia and acute lymphoblastic leukemia, as well as other cancers.

Sunvozertinib was granted breakthrough therapy designation by the FDA for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer harboring an EGFR exon 20 insertion mutation.

PT217 is a first-in-class treatment targeting DLL3 and CD47 for patients with extensive-stage small cell lung cancer.

The FDA’s fast track designation of LYT-200 in this population is supported by an ongoing phase 1/2 clinical trial.

The Oncologic Drugs Advisory Committee determined that minimal residual disease could serve as an accelerated approval end point in multiple myeloma clinical trials.

An investigational new drug application for UGN-103 was accepted by the FDA. A phase 3 study to assess the safety and efficacy of the agent in low-grade intermediate-risk non-muscle invasive bladder cancer is anticipated.

The FDA has approved Lumisight and the Lumicell Direct Visualization System for fluorescence imaging in adult patients with breast cancer.

The FDA approved adjuvant alectinib following tumor resection for the treatment of patients with ALK-positive non-small cell lung cancer.

Following an investigation that began in November 2023, the FDA now requires boxed warnings regarding T-cell malignancies on all BCMA- and CD19-directed T-cell products.

This breakthrough therapy designation of ziftomenib marks the first of its kinds in NPM1-mutant acute myeloid leukemia.

Patients with Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma in situ now have a new treatment option following the FDA’s approval of nogapendekin alfa.

The FDA has approved the new drug application of tovorafenib for the treatment of pediatric low-grade glioma.

The FDA accepted the supplemental biologics license for dostarlimab plus standard-of-care chemotherapy for all patients with primary advanced or recurrent endometrial cancer and set a Prescription Drug User Fee Act action date of August 23, 2024.

Trastuzumab-strf, a biosimilar of trastuzumab, has received FDA approval for treating HER2-overexpressing breast cancer and metastatic gastric cancer.

Tisotumab vedotin is now an FDA-approved treatment for patients with recurrent or metastatic cervical cancer.

Recently published guidelines from the FDA aim to expand eligibility criteria in clinical trials with recommendations for laboratory values, washout periods, and patient performance status.

The FDA issued a ‘safe to proceed’ for the investigational new drug application for PRAME TCR/IL-15 NK for relapsed or refractory myeloid malignancies.

With an FDA orphan drug designation now granted to IGNK001, clinical trials investigating the agent in acute myeloid leukemia are planned to initiate in the US.