News

"Pralsetinib has broad potential to address the medical needs of patients with RET-altered cancers, who have not traditionally benefited from targeted therapy even though their tumors have a known disease driver."

In an interview with Targeted Oncology, Xiuning Le, MD, PhD, discussed the results of the phase II VISION study, which evaluated tepotinib in patients with advanced non-small cell lung cancer and harbor the MET exon 14 skipping mutation. She also highlighted the role of liquid biopsy in this space.

The FDA approved avelumab as a frontline maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma who have not progressed with frontline platinum-based chemotherapy.

The addition of trastuzumab to chemotherapy in patients with uterine serous carcinoma had superior outcome compared with chemotherapy alone.

Here is a look back at the FDA happenings from the month of June 2020.

A rolling Biologics License Application has been initiated for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma

"We are excited about cirmtuzumab’s potential for the treatment of patients with ROR1-expressing cancers, including mantle cell lymphoma, chronic lymphocytic leukemia, HER2-negative breast cancer, and other solid tumors, and look forward to further advancing its development to benefit patients with significant unmet medical needs."

"The launch of these 3 liquid biopsy assays exemplifies our commitment to providing the most comprehensive oncology menu for our clients as a one-stop-shop for their testing needs."

In an interview with Targeted Oncology, Phillipe Moreau, MD, discussed the findings from the IKEMA trial and what these date mean for the treatment landscape of relapsed multiple myeloma.

Amelie G. Ramirez, DrPH, addressed disparities among the Hispanic community in the United States and the steps necessary to overcome them.

"Patients with unresectable or metastatic MSI-H colorectal cancer have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options."

A New Drug Application was submitted to the FDA seeking accelerated approval of eflornithine in combination with sulindac for the treatment of adult patients with familial adenomatous polyposis.

"We are very pleased to receive Fast Track Designation for Betalutin in marginal zone lymphoma, which recognizes the clear need for new therapeutic options for patients with advanced marginal zone lymphoma patients who no longer respond to the therapies they have been receiving."

In a single-institution study, investigators found a correlation between certain genotypes and comorbidities and trastuzumab-induced cardiotoxicity among patients with HER2-positive breast cancer.

Targeted Oncology reviews trending news online for the week of June 26, 2020, including recent news from the FDA, updates in oncology, and new information regarding COVID-19.

In an interview with Targeted Oncology, John P. Leonard, MD, discussed the results of the phase 2 study of tazemetostat, the drug approval for relapsed/refractory follicular lymphoma, and the role of tazemetostat in the community setting.

TXR-311 has demonstrated activity in validation studies and has selectivity for killing hepatocellular carcinoma tumor cells.

"This interim clinical and translational data add further confidence to the potential patient benefit of selective AXL inhibition with bemcentinib, to reverse resistance to immune checkpoint inhibitors in selected cAXL-positive patients who have relapsed on immunotherapy."

In an interview with Targeted Oncology, Anthony Mato, MD, discussed the findings of venetoclax interruptions or discontinuations observed in patients with relapsed/refractory chronic lymphocytic leukemia who received the combination of venetoclax plus rituximab in the phase 3 MURANO study.

All patients with relapsed/refractory chronic lymphocytic leukemia should be evaluated for both complex karyotypes and del17p prior to initiating treatment, and all patients with complex karyotypes should be considered candidates for alternative combination therapy.

Liso-cel administration in the outpatient setting was implemented successfully in 3 clinical trials at academic and nonacademic medical centers.

During the Virtual 25th Congress of the European Hematology Association (EHA), a group of physicians described their experiences and recommendations for managing patients with myeloid malignancies during the COVID-19 pandemic and after.

Pembrolizumab received FDA approval for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by either surgery or radiation.

“Cervical cancer screening rates are suboptimal among Asian American women, despite considerable efforts to improve Pap test screening."

If validated, the investigators believe that this non-invasive test could help detect renal cell carcinoma earlier on, thereby reducing the mortality of the disease.

The phase 2 TELLOMAK clinical trial is no longer on a partial clinical hold. As a result, trial enrollment with continue in patient with advanced T-cell lymphomas.

The website Project Patient Voice has been launched by the FDA, which is a new website that will share publicly available information on patient-reported outcomes from clinical trials for cancer.

Patients receiving high-dose therapy for mantle cell lymphoma are at a higher risk of treatment failure if they have mutations in the TP53 or KMT2D genes, according to new research.

MET amplifications are found in up to 10% of patients with EGFR-mutant NSCLC who progress on first- or second-generation EGFR TKIs and in up to 25% of those who progress on a third-generation EGFR TKIs, necessitating the need for treatment options in the population.

With a Fast Track designation, the development of seviprotimut-L will be facilitated and expeditiously reviewed by the FDA to address an unmet medical need for patients with stage IIB and IIIC melanoma,