October 2023 Brief

The fast track designation for AVB-001 granted by the FDA recognizes its potential as a treatment option for patients with relapsed/refractory ovarian cancer.

Phase 2 studies are investigating BDC-1001 in HER2-positive gastroesophageal, colorectal, breast, and endometrial cancers.

The FDA and Takeda have decided to voluntarily withdraw mobocertinib, a drug for patients with EGFR exon20 insertion mutation-positive non–small cell lung cancer.

Top-line results from a phase 2b trial evaluating FG001 for patients with high-grade glioma are expected by the end of November.

The decision marks the first time the FDA has relied on a single externally controlled trial to support a potential approval in oncology.

BI 764532 is under investigation in a first-in-human phase 1 trial for patients with extensive-stage small cell lung cancer and extrapulmonary neuroendocrine carcinoma.

The CRCdx RAS mutation detection kit was designed to detect 35 variants of KRAS and NRAS exon 2, 3, and 4 somatic mutations in patients with colorectal cancer.

The FDA’s Oncologic Drug Advisory Committee met to discuss the supplemental new drug application for sotorasib for the treatment of adult patients with KRAS G12C mutated non–small cell lung cancer.

Patients who are currently benefiting from lacutamab may continue to receive the treatment while the clinical hold is in place.

The FDA completed its inspection of a third-party filler, and no additional data or trials have been requested for resubmission.

The next-generation diagnostic tool is approved for companion diagnostic use with selpercatinib for select solid locally advanced and metastatic tumors.

SLS009 represents a promising solution for patients with acute myeloid leukemia, addressing a significant unmet medical need. Top-line data on the agent are expected by the end of the year.

Encorafenib combined with binimetinib is now an FDA-approved option for patients with BRAF V600E-mutated non-small cell lung cancer.

This regulatory decision follows the recent FDA approval of encorafenib plus binimetinib for adult patients with metastatic non-small cell lung cancer harboring a BRAF V600E mutation.

Positive findings from CheckMate-76K have led the FDA to approve adjuvant nivolumab monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma.

A phase 1 trial of TERN-701 for chronic myeloid leukemia plans to start patient screening in December 2023, with initial data expected to be released in the second half of 2024.

The FDA has approved pembrolizumab in the perioperative setting for resectable stage II, IIIA, or IIIB non–small cell lung cancer.

A fast track designation has been granted to DOC1021 by the FDA for the treatment of patients with glioblastoma multiforme.

Ivosidenib tablets have received FDA approval for the treatment of adult patients with relapsed/refractory myelodysplastic syndromes with a susceptible IDH1 mutation.

TTX101 will be studied in a phase 1/2a clinical trial for patients with recurrent glioblastoma.

Preclinical data of MB-109 from the American Association for Cancer Research Annual Meeting in 2022 support MB-109 as a potential treatment for patients with recurrent glioblastoma.

Toripalimab in combination with gemcitabine and cisplatin, as well as toripalimab monotherapy, has been granted approval by the FDA for patients with recurrent, unresectable, or metastatic nasopharyngeal carcinoma.

SLS009 showed promising efficacy in a phase 1 trial and now has been granted a fast track designation by the FDA for the treatment of relapsed or refractory peripheral T-cell lymphoma.

Roginolisib, a first-in-class small molecule allosteric modulator of PI3Kδ, has been given the green light by the FDA to continue studies for patients with solid and hematologic malignancies.

With the clinical hold lifted by the FDA, the phase 1 trial of XMT-2056 will continue to evaluate the agent's safety, tolerability, and efficacy in patients with HER2-expressing solid tumors.