News

The FDA has accepted a supplemental biologics license application for adjuvant pembrolizumab and granted it priority review as a treatment for patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

In an interview with Targeted Oncology™, Michael J. Overman, MD, discussed targeted rare genomic alterations in colorectal cancer.

In an interview with Targeted Oncology™, Statish Shah, MD, the medical director of Gettysburg Cancer Center, discusses the OneOncology partnership in more detail and how it will benefit patients. 

Guiseppe Curigliano, MD, discusses the design and results of the HER2CLIMB-02 study which evaluated the efficacy of tucatinib in combination with trastuzumab and capecitabine in HER2-positive breast cancer patients with and without brain metastases compared to placebo.

A significantly improved and clinically meaningful progression-free survival was accomplished by combining polatuzumab vedotin and R-CHOP in patients with previously untreated diffuse large B-cell lymphoma compared with R-CHOP alone, according to results of the phase 3 POLARIX trial.

A highly statistically significant improvement in progression-free survival has been observed with the HER2 monoclonal antibody trastuzumab deruxtecan treatment compared with trastuzumab emtansine in patients with HER2-positive unresectable or metastatic breast cancer, meeting the primary end point of the phase 3 DESTINY-Breast03 trial.

Cathy Eng, MD, FACO, FASCO, discusses how biomarkers are being explored to aid the treatment of anal cancers.

Peter Martin, MD, explains the importance of reviewing real-world databases and the results of a real-world study of treatment patterns and outcomes of patients with mantle cell lymphoma.

In an interview with Targeted Oncology, Clara Hwang, MD, discussed how real-world evidence uncovered multiple disparities related to COVID-19 and patients with cancer.

In an interview with Targeted Oncology™ following a presentation of the study protocol at the 2021 American Society of Clinical Oncology Annual Meeting, Susana K. Banerjee, PhD, explained the progress of ENGOT-ov60/GOG3052/RAMP 201 in detail.

Rodney P. Rocconi, MD, discusses a subgroup analysis of the phase 2b VITAL study in which the efficacy of maintenance Vigil immunotherapy is explored in patients with newly diagnose advanced ovarian cancer who are homologous recombination proficient.

A non-randomized, open-label trial of AIC100, an autologous chimeric antigen receptor T-cell agent for the treatment of relapsed/refractory thyroid cancer, is currently recruiting patients at the Weill Cornell Medical College in New York, under the supervision of Koen van Besien, MD, PhD.

The FDA has issued a complete response letter to the developer of eflapegrastim, for which a biologics license application was submitted for the treatment of chemotherapy-induced neutropenia. The FDA has cited manufacturing deficiencies and is requiring that the facilities be reinspected.

In an interview with Targeted Oncology™, Thomas Powles, MD, MBBS, MRCP, discussed the latest research around enfortumab vedotin in locally advanced or metastatic urothelial cancer.

To address over expression of the prostate specific membrane antigen in men with prostate cancer and other solid tumors, a phase 1 study of the novel anti-PSMA antibody drug conjugate, ARX517, has been administered to the first patient.

Patients with advanced non-small cell lung cancer treated with cemiplimab in combination with platinum-doublet chemotherapy saw an improvement in overall survival in comparison with patients who received chemotherapy alone, meeting the primary end point of the phase 3 EMPOWER-Lung 3 study.

An orphan drug designation has been granted to the CD40 agonistic monoclonal antibody, sotigalimab, for the treatment of patients with soft tissue sarcoma.

The FDA has accepted and granted priority review to a biologics license application for pembrolizumab for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

Research in the solid tumors arena around the combination of the oncolytic virus technology CF33-CD19 and the CD19-targeting CAR placental-derived T-cell therapy CyCART-19, is underway to explore it’s potential in this patient population.

Following the success of a phase 1 study that showed its potential for accelerated FDA approval in the future, the WEE-1 inhibitor, ZN-c3 has been dosed for the first time in the newly launched phase 2 study, which is exploring the agent for the treatment of adult women with recurrent or persistent uterine serous carcinoma.

Stephanie Lee, MD, MPH, discusses the study of ruxolitinib plus best available therapy as a second-line treatment for patients with chronic graft-versus-host disease.

The combination of plinabulin with docetaxel showed improvement in overall survival compared with docetaxel alone as treatment of patients with second- and third-line non –small cell lung cancer with EGFR wild type, meeting the primary end point of the phase 3 DUBLIN-3 clinical trial.

In an interview with Targeted Oncology™, Kamran A. Ahmed, MD, discussed the novel treatment strategy of combining radiotherapy with intrathecal trastuzumab/pertuzumab as well as and the rationale behind the combination.

In an interview with Targeted Oncology™, Rhonda L. Bitting, MD, discussed the efficacy results and key takeaways of a study investigating low-dose paclitaxel plus pembrolizumab in patients with platinum-refractory UC. 

Bristol Myers Squibb has decided to withdraw the approval for romidepsin, a histone deacetylase inhibitor, for the treatment of adults with peripheral T-cell lymphoma who received at least 1 prior therapy after a confirmatory phase 3 study missed its primary end point.

The FDA has accepted the supplemental biologics license application submitted for atezolizumab as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumors express PD-L1≥1%, as determined by an FDA-approved test and granted it priority review.

Here is a look back FDA happenings from July 2021.

In an interview with Targeted Oncology™, Joseph Kim, MD, an associate professor of internal medicine at the Yale School of Medicine, discuss the lack of clinical benefit of sapanisertib for the treatment of TSC1/TSC2mutated mUC.

Treatment with ivosidenib tablets in combination with azacitidine led to improvement in event-free survival in patients with previously untreated IDH1-mutated acute myeloid leukemia, meeting the primary end point of the phase 3 AGILE study.

The FDA has granted a fast track designation for nemvaleukin alfa, an interleukin-2 variant immunotherapy, for the treatment of mucosal melanoma.