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Based on phase 3 findings, F-627 appears at least as efficacious and safe as pegfilgrastim, which is the current standard of care, demonstrating strong and durable benefit in patients with breast cancer.

In an interview with Targeted Oncology, Julie R. Gralow, MD, discussed the findings from the KAITLIN study of T-DM1 in early-stage breast cancer.

The addition of bortezomib consolidation therapy or bortezomib maintenance to the immunochemotherapy regimen rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone improved progression-free survival in patients with mantle cell lymphoma in the post-transplant setting, according to a comparative analysis, CALGB/Alliance 50403 trial.

“By retrospectively analyzing data from the adjuvant BIG 2-98 trial, we demonstrated that overweight and obese patients treated with a docetaxel-based chemotherapy regimen presented with a worse disease-free and overall survival compared with average weight patients treated with the same chemotherapy regimen."

The last patient with advanced hepatocellular carcinoma was enrolled on the phase 2 HEPANOVA trial, which is investigating the combination of Tumor Treating Fields and sorafenib. The combination showed safety and tolerability for patients in an interim analysis.

The FDA granted Priority Review to pembrolizumab as treatment of patients with relapsed or refractory classic Hodgkin lymphoma.

Chimeric antigen receptor T-cell therapy when administered to patients with non-follicular low-grade lymphoma may experience different efficacy outcomes than patients with aggressive B-cell lymphomas, according to a single-institution retrospective data.

In an interview with Targeted Oncology, Matthew Davids, MD, MMSc, discussed the long-term follow-up results of ibrutinib in combination with umbralisib as treatment of patients with chronic lymphocytic leukemia and mantle cell lymphoma.

The approval of ruxolitinib may have generated an increased awareness around myelofibrosis, ultimately improving the overall management of this patient population.

In an interview with Targeted Oncology, Naval G. Daver, MD, discussed the safety and efficacy findings of margolimab as treatment of patients with TP53-positive AML and high-risk MDS.

The FDA has issued a complete response letter in regard to the applications for potential accelerated approval of pembrolizumab in combination with lenvatinib as treatment of patients with previously untreated, unresectable hepatocellular carcinoma.

The FDA has placed a clinical hold on the MELANI-01 clinical trial evaluating UCARTCS1A, a chimeric antigen receptor T-cell therapy.

FDA has granted approval to the combination regimen decitabine and cedazuridine as treatment of adult patients with myelodysplastic syndromes under multiple indications.

At the recent 2020 American Society of Clinical Oncology Virtual Scientific Program, key research evaluating the use of anti-HER2 agents were highlighted across multiple solid tumors, including gastric or gastroesophageal junction adenocarcinoma, colorectal cancer, and non–small cell lung cancer.

“The data presented today further reinforce the potential of ripretinib to provide meaningful clinical benefit to patients with advanced gastrointestinal stromal tumor."

In an interview with Targeted Oncology, Chung-Han Lee, MD, PhD, discussed the findings from the phase 2 study of pembrolizumab plus lenvatinib in patients with metastatic clear cell renal cell carcinoma who have progressed on prior immune checkpoint inhibitor therapy.

A phase 3 study evaluating pracinostat in combination with azacitidine for patients with acute myeloid leukemia ineligible for standard intensive chemotherapy has been discontinued.

In an interview with Targeted Oncology, Claire Harrison, MD, FRCP, FRCPath, discussed results from the combination of navitoclax and ruxolitinib, as explored in a phase 2 study.

A new randomized placebo-controlled study finds patients with acute myeloid leukemia who cannot undergo intensive chemotherapy have improved outcomes when given venetoclax in addition to low-dose cytarabine.

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

Long-term follow-up results from the study were presented in a poster at the virtual 2020 European Society of Medical Oncology World Congress on Gastrointestinal Cancer meeting.

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.

In an interview with Targeted Oncology, Gaël Roué, PhD, discussed the rationale for evaluating TG-1701 in combination with ublituximab and umbralisib in ibrutinib-resistant MCL.

In an interview with Targeted Oncology, Danny Rischin, MD, director, discussed the findings from the EMPOWER-CSCC-1 study of cemiplimab in advanced cutaneous squamous cell carcinoma that led to the drug’s FDA approval.

"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.