May 2024 Brief

The FDA is considering a subcutaneous nivolumab formulation for various solid tumors based on promising data from the phase 3 CheckMate -67T trial. A target action date has been set for December 29, 2024.

A clinical trial to evaluate EIS-12656 in patients with specific types of advanced solid tumors will begin following the clearance of an investigational new drug application from the FDA.

If approved, zenocutuzumab would be the first targeted therapy for neuregulin 1 fusion-positive lung and pancreatic cancers.

The FDA has approved ColoSense, a stool screening test with 93% accuracy for colon cancer in average-risk adults over the age of 45. This noninvasive option may boost early detection rates.

With the clearance of an investigational new drug application for BTX-9341 from the FDA, a phase 1 trial will evaluate the agent in HR-positive/HER2-negative breast cancer.

9MW2821 was granted an orphan drug designation from the FDA and is being evaluated for the potential treatment of esophageal cancer, as well as other cancers.

If approved, this would mark the first Epstein-Barr virus-related mRNA therapeutic cancer vaccine.

SNB-101, a nanoparticle drug for small cell lung cancer, received a fast track designation from the FDA for expedited development and review.

With the FDA clearance of an investigational new drug application for SynKIR-310, a phase 1 trial evaluating the agent in relapsed/refractory B-cell non-Hodgkin lymphomas will begin.

The FDA has approved one of the first human papillomavirus self-collection solutions for use in the US.

The FDA has given the novel agent NVL-655 a breakthrough therapy designation for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer.

The FDA has withdrawn the approval for infigratinib to treat patients with cholangiocarcinoma. A phase 3 study comparing it to standard treatment has also been halted.

Data from the phase 3 INAVO120 trial support the breakthrough therapy designation granted by the FDA to inavolisib, palbociclib, and fulvestrant for the treatment of PIK3CA-mutated breast cancer.

RAG-01 has received an FDA fast track designation and is being investigated for the treatment of non-muscle invasive bladder cancer.

The May 2024 ODAC meeting discussed FDARA's impact on pediatric cancer drug development, emphasizing international collaboration and early regulatory engagement.

The protocol for a phase 3 clinical trial testing a new combination therapy targeting advanced prostate cancer has received approval from the FDA.

VCN-01, an adenovirus therapy, received fast track designation from the FDA for treating metastatic pancreatic cancer in combination with standard chemotherapy.

Data from the phase 3 INAVO120 trial support the priority review granted by the FDA to inavolisib, palbociclib, and fulvestrant for the treatment of PIK3CA-mutated breast cancer.

An FDA advisory committee recommends approval for a new blood test for colorectal cancer screening, potentially offering a more convenient option that could boost screening rates.

Zanidatamab could become the first FDA-approved, HER2-targeted treatment for HER2-positive biliary tract cancer.

The approval of selpercatinib marks the first targeted therapy for pediatric patients with RET gene alterations in solid and thyroid tumors.

A rolling new drug application is being submitted to the FDA for an ovarian cancer treatment combination of avutometinib and defactinib.

AFM24 combined with atezolizumab has received a fast track designation from the FDA for treating advanced/metastatic non-small cell lung cancer without activating EGFR mutations.

A Prescription Drug User Fee Act target action date of September 25, 2024, has been set for the application of pembrolizumab plus chemotherapy in advanced mesothelioma.

The FDA has approved a phase 1, first-in-human trial to evaluate the safety and potential effectiveness of ACTM-838, a novel immunotherapy drug for advanced solid tumors.

The FDA has approved the CAR T-cell therapy liso-cel for the treatment of patients with mantle cell lymphoma.

The FDA has granted a fast track designation to AGuIX, a gadolinium-based nanodrug currently under evaluation for treating malignant gliomas and glioblastoma.

Zolbetuximab could become the first CLDN18.2-targeted therapy approved for this patient population in the US.

The FDA granted a regenerative medicine advanced therapy designation to TSC-100 and TSC-101 for hematologic malignancies based on encouraging ALLOHA trial data, offering expedited development and review.