News

At median follow-ups of 9.2 and 9.9 months in a phase 1b/2 study, the confirmed objective response rate with the TPST-1120 triplet was 30% vs 13.3% in the control arm, respectively.

The CXCL 12 inhibitor delivered a 50% overall survival rate at 18 months in the GLORIA trial, and its manufacturer intends to seek FDA guidance on further trial design.

Hatem Soliman, MD, discusses some of the exciting research that is ongoing for patients with HER2-positive breast cancer.

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

Researchers identified different functions of groups of intraepithelial T cells (T-IELs) throughout the gastrointestinal tract, which could help inform future immunological treatment for patients with colorectal cancer.

Data from the PROpel study support the FDA’s approval of olaparib plus abiraterone for patients with metastatic castration-resistant prostate cancer.

A statistically significant overall survival benefit was observed with perioperative pembrolizumab in the phase 3 KEYNOTE-671 trial for patients with stage II, IIIA or IIIB non–small cell lung cancer.

The disruption of the fine-tuned androgen receptor protein multivalent interactions might contribute to AR-related human pathologies.

Progression-free survival and overall survival data were maintained with fixed-duration venetoclax plus rituximab among patients with relapsed/refractory chronic lymphocytic leukemia

The CAR-HEMATOTOX score was positively associated with identifying the risk of poor treatment outcomes for patients with mantle cell lymphoma treated with chimeric antigen receptor T-cell therapy.

Heather Wakelee, MD, discusses the efficacy findings from the phase 3 KEYNOTE-671 clinical trial evaluating the addition of pembrolizumab to neoadjuvant platinum-based chemotherapy followed by resection and adjuvant pembrolizumab alone for patients with early-stage non–small cell lung cancer.

Findings of the phase 1b/2 EPCORE CLL-1 trial were presented during the International Workshop on CLL.

Findings from the phase 1/2 BRUIN trial of show a distinct genetic evolution in patients with B-cell malignancies. However, the baseline BTK mutations did not impede pirtobrutinib’s effectiveness.

Benny Weskler, MBA, MD, FACS, FACCP, discusses the introduction of immune checkpoint inhibitors in the neoadjuvant setting for patients with non–small cell lung cancer.

The treatment landscape for patients with resected stage III colon cancer has undergone a significant change, following publication of an International Development and Education Award presentation abstract in the August 2023 Journal of the National Comprehensive Cancer Network.

Currently, 6 separate bills have come out of congressional committees to increase pharmacy benefit managers regulation, with more transparency being the common factor.

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

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

Investigators presented results from new studies at the 2023 ASTRO Meeting. The data showcase a new assay’s performance in predicting metastasis-free survival and distant metastasis.

Additional findings from the phase 3 LIGHTHOUSE trial support flotufolastat F 18 injection and its approval in the prostate cancer space.

The search continues for unique single and combination agents used with anti–PD-1/ PD-L1 approaches.

The improvement in progression-free survival in the venetoclax arm of the study was not statistically significant compared to the control arm but results still trend positively.

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.

Meeting a primary end point, KEYNOTE-123 study shows promise for pembrolizumab as an adjuvant muscle-invasive bladder cancer treatment.

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.

Although conventional chemotherapy, surgery, and radiotherapy are the foundation of treatment, adverse events such as risk of infection—bacterial and fungal—present clinical challenges.

According to a follow-up survey by the National Comprehensive Cancer Network, 86% of cancer centers included are still experiencing oncology drug shortages.

Here is a lookback at all of the FDA happenings from September 2023.

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