Nichole Tucker

In New York City, high cases of COVID-19 continue to be reported with a high prevalence among racial and ethnic minorities.

The FDA granted Fast Track designation to the glutamate-binding molecule, anhydrous enol-oxaloacetate, for the treatment of patients with newly diagnosed glioblastoma multiforme.

In the phase 3 DUO clinical trial, treatment with duvelisib improved health-related quality of life in patients with relapsed or refractory chronic lymphocytic leukemia compared with ofatumumab.

"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."

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.

"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."

"Available therapies upon progression after first-line chemotherapy in recurrent or metastatic cervical cancer are limited, and there is a significant unmet need for new treatment options."

"The Orphan Drug Designation we received from the FDA is of significant importance in accelerating the development of PBP1510 to provide better treatment for pancreatic cancer."

"The FDA approval of Phesgo reflects our commitment to improving outcomes for the many people living with HER2-positive breast cancer."

"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 an interview with Targeted Oncology, Neal Shore, MD, director, Carolina Urologic Research Center, discussed the OS analysis for the phase 3 ARAMIS study and explained a match-adjusted indirect comparison. He also discussed how these data connect with presentations around the 3 approved agents for nmCRPC being presented at AUA 2020.

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.

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.

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

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.

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,

In an interview with Targeted Oncology, Michael Schuster, MD, discussed the findings in the phase 2 SADAL study and the importance of the FDA approval of selinexor for the treatment of relapsed/refractory diffuse large B-cell lymphoma.

The FDA has announced plans to convene a meeting of the Oncologic Drugs Advisory Committee to review the Biologic License Application for belantamab mafodotin as treated of patients with relapsed or refractory multiple myeloma.

During a debate made available as part of the 2020 National Comprehensive Cancer Network Virtual Annual Conference, Deborah Stephens, DO, and Mazyar Shadman, MD, MPH, discussed the most optimal frontline therapy for chronic lymphocytic leukemia.

IMpassion031, a clinical trial of atezolizumab plus chemotherapy in patients with triple-negative breast cancer, has met its primary end point.

A liposomal irinotecan combination was granted FDA Fast Track designation for the treatment of untreated and unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma.

In an interview with Targeted Oncology, Andrew L. Coveler, MD, discussed the phase 1 trial study of SEA-CD40 combined with a chemotherapy regimen, which he recently presented during the ASCO Virtual Scientific Program.

"We can potentially offer a new treatment option for patients with high-risk HR-positive, HER2-negative early breast cancer. "

"We are pleased to bring a new treatment choice to relapsed SCLC patients."

“These results, complimented with a favorable safety profile, indicate the utility of this novel immunological combination as a potential treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma."

"Breakthrough designation for the companion diagnostic is a big step forward in our endeavor to ensure that more clinicians can have quicker access to comprehensive genomic information."

In an interview with Targeted Oncology following the American Urological Association Virtual Annual Meeting, Eric A. Klein, MD, discussed the importance of molecular testing in Caucasian and African American patients with newly diagnosed prostate cancer. He also discussed the pros and cons of active surveillance.

Glioblastoma currently has a dismal survival rate of only 14.6 months from its diagnosis. We believe berubicin, which based on limited clinical data appears to be the first anthracycline to cross over the blood-brain barrier in adults, provides a potentially novel therapy for the treatment of malignant gliomas.