Jordyn Sava

Pembrolizumab plus lenvatinib demonstrated promising clinical activity with no unexpected toxicities in patients with malignant pleural mesothelioma, according to results from the PEMMELA study.

While treatment with pembrolizumab and lenvatinib vs lenvatinib alone seemed to have survival benefit in patients with unresectable hepatocellular carcinoma, the primary end points of the trial were missed.

The FDA has approved darolutamide tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer.

The FDA has approved fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

The FDA accepted an investigational new drug application allowing for the start of a phase 1 trial to evaluate the tolerability of AVB-101 in patients with platinum resistance ovarian cancer.

High objective response and complete response rates observed with mosunetuzumab in patients with relapsed/refractory follicular lymphoma.

In an interview with Targeted Oncology, Christopher Nevala-Plagemann, MD, discussed the key takeaways of his research on the best treatment strategies for patients with left sided RAS or RAF wild-type metastatic colorectal cancer.

The LYNK-003 trial evaluating olaparib monotherapy or in combination with bevacizumab in patients with unresectable or metastatic colorectal cancer who have not progressed following first-line induction has ended due to futility.

The phase 3 TAVT45CO2 study investigating TAVT-45 in patients with metastatic castrate-sensitive prostate cancer and metastatic castrate-resistant prostate cancer has finished enrollment.

Findings from a phase 1 study concluded zandelisib given to patients with relapsed/refractory B-cell malignancies at 60 mg once daily in an intermittent dosing schedule reflected in a positive safety profile.

Pivotal phase 3 result have led the FDA to accept a biologics license applications for omidubicel as treatment of patients with blood cancers requiring allogenic hematopoietic stem cell transplant. The applications has been accepted for priority review.

A phase 1/2 clinical trial examining the combination of afuresertib, sintilimab, and chemotherapy in patients with specific solid tumors who were resistant to anti-PD-1/PD-L1 therapy has dosed its first patient.

The CYAD-101-002 trial may resume after the FDA lifted the partial clinical hold to evaluate risk to study patients with metastatic colorectal cancer.

A look back at all of the FDA happenings of July 2022.

In the first comparison of zanubrutinib vs chemoimmunotherapy, zanbrutinib was shown to improve progression-free survival in patients with treatment-naïve chronic lymphocytic leukemia and small lymphocytic lymphoma, and may be less toxic.

Sarah C. Rutherford, MD, discussed how findings from her research could impact the current guidelines for follicular lymphoma.

The FDA has accepted the biologics license application for N-803 as a treatment for patients with Bacillus Calmette–Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma in situ with or without Ta or T1 disease.

Mature survival data from the phase 3 ICON8 trial revealed no significant difference between administering weekly dose-dense chemotherapy and standard 3-weekly chemotherapy as front-line therapy for patients with epithelial ovarian cancer.

In an interview with Targeted Oncology, Jamie Brett and Seth Wander, MD, PhD, discussed recent findings regarding CDK4/6 for patients with hormone receptor-positive metastatic breast cancer with ESR1 alterations.

IRX-2 did not demonstrate a statistically significant improvement in event-free survival as neoadjuvant therapy vs standard of care in patients with newly diagnosed, stage II, III, or IVA squamous cell carcinoma of the oral cavity, according to data from the phase 2 INSPIRE trial.

A pre-NDA meeting with the FDA discussed planned patient follow-up for patients with ROS1+ advanced non-small cell lung cancer in cohorts of the ongoing TRIDENT-1 study of repotrectinib.

Following positive phase 1/2 results of DS-7300 use in patients with extensive-stage small cell lung cancer, a phase 2 study has dosed its first patient with the experimental agent.

The experimental combination of tremelimumab, durvalumab, and stereotactic body radiotherapy lack overall surival benefit in anaplastic thryoid cancer, phase 1 findings show.

The FDA has accepted an application for the approval of fam-trastuzumab deruxtecan-nxki for the treatment of select adult patients with unresectable or metastatic HER2-low breast cancer.

Focused cancer centers increased hemithyroidectomy 2 years prior to the release of the newest American Thyroid Association guidelines. However, only community cancer program hospitals began to increase hemithyroidectomy utilization following release of guidelines.

In an interview with Targeted Oncology, Vignesh Packiam, MD, discussed the research of gemcitabine plus cabazitaxel and pembrolizumab in patients with non-muscle invasive urothelial carcinoma who are unresponsive to docetaxel.

The phase 3 CALGB 9343 study significantly changed prescription patterns for patients with metastatic colorectal cancer, according to a presentation at the International Society for Pharmacoeconomics and Outcomes Research 2022.

Data revealed that a longer time to treatment discontinuation seen with asciminib favored its relative tolerability, correlating with the better-observed safety profile, according to data presented at the International Society for Pharmacoeconomics and Outcomes Research 2022

In an interview with Targeted Oncology, Gerald Falchook, MD, discusses the efficacy and safety of cobolimab with or without nivolumab and dostarlimab, as evaluated in the phase 1 AMBER trial.

The FDA has granted fast track designation and rare pediatric disease designation for WU-CART-007 as treatment for patients with relapsed or refractory T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma.