Nichole Tucker

Real-world trial results demonstrated nivolumab had comparable overall survival results with those observed in the phase 3 CheckMate 025 study as treatment of patients with advanced renal cell carcinoma who received 1 or more prior lines of therapy.

During a presentation at the 2020 Society of Hematologic Oncology Virtual Annual Meeting, Andrzej Jakubowiak, MD, PhD, reviewed clinical trials of CAR T-cell therapy in multiple myeloma and the emergence of CAR T cells against SMALF7, GPRC5D, and CD229.

A Fast Track designation has been granted by the FDA to EPI-7386, a selective androgen receptor inhibitor, which is a potential treatment for adult patients with metastatic castration-resistant prostate cancer that is resistant to standard-of-care therapy.

Patients with classic Hodgkin lymphoma and human immunodeficiency virus were found to have similar clinical outcomes compared with patients with cHL and no HIV, according to an analysis presented during the eighth annual virtual meeting of the Society of Hematologic Oncology.

A higher percentage of patients with nonmetastatic castration-resistant prostate cancer were alive at 3 years on treatment with darolutamide compare with placebo, according to published results from the final analysis of the phase 3 ARAMIS clinical trial.

Prognostic factors in patients with myelofibrosis treated with a myeloablative busulfan/fludarabine conditioning regimen prior to allogeneic stem cell transplantation in a single-institution analysis showed that a time from diagnosis to transplant of more than 12 months was associated with poorer overall survival and displayed a trend toward higher non-relapse mortality.

The combination of atezolizumab and paclitaxel was not effective for the treatment of patients with treatment-naïve inoperable locally advanced or metastatic triple-negative breast cancer, according to an FDA alert.

The combination of nivolumab plus ipilimumab demonstrated long-term survival and response benefits as treatment of poor- to intermediate-risk patients with advanced renal cell carcinoma with sarcomatoid features compared with sunitinib, according to published results from the phase 3 CheckMate 214 clinical trial.

A novel Bcl-2 inhibitor, APG-2575, has been granted an Orphan Drug designation by the FDA for the treatment of patients with chronic lymphocytic leukemia.

In an interview with Targeted Oncology Guillermo Garcia-Manero, MD, discussed the key findings from the QUAZAR AML-001 study and the importance of the FDA approval of CC-486 in post-remission acute myeloid leukemia.

Clinically meaningful antitumor activity was observed with capmatinib in patients with metastatic non–small cell lung cancer who harbor MET exon 14 skipping mutations, according to results from the phase 2 GEOMETRY mono-1 clinical trial.

The benefits and risks of osimertinib as second- or later-line treatment of patients with EGFR-positive non–small cell lung cancer that were reported when the agent was first approved, have now been confirmed, according to data from a real-world study conducted in Japan.

Sequential afatinib followed by osimertinib led to encouraging outcomes in patients with deletion 19 (del19) or L858R epidermal growth factor receptor (EGFR)-mutant non–small cell lung cancer, according to the final analysis results from the real-world study, GioTag.

The FDA has granted an Orphan Drug designation to rhenium nanoLiposomes for the treatment of patients with recurrent glioblastoma.

A real-world study assessed the performance of this system in patients with differentiated thyroid cancer and discovered that the system is reliable for predicting short-term outcomes.

The FDA granted approval to the oral hypomethylating agent, CC-486 (azacitidine tablets, Onureg), as a maintenance treatment for adult patients with acute myeloid leukemia who achieved a first complete remission or with incomplete blood count recovery after intensive induction chemotherapy and who are unable to complete intensive curative therapy.

The question of whether patients with asymptomatic advanced-stage follicular lymphoma should undergo watch-and-wait observation or start treatment immediately was addressed at the 2020 Debates and Didactics in Hematology and Oncology during a debate between Jean Louise Koff, MD, MS, and James O. Armitage, MD.

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

Experts in myeloproliferative neoplasms find janus kinase inhibitors to be particularly important to the armamentarium for the treatment of myelofibrosis. With only 2 FDA-approved agents, fedratinib and ruxolitinib, and the inevitability that not all patients will derive benefit, and some will develop resistance, the option of moving beyond JAK inhibition is widely discussed.

In an interview with Targeted Oncology, Phillip C. Hoffman, MD, professor of medicine, University of Chicago, and chairperson of ODAC, discussed ODAC operations during the COVID-19 pandemic and the most recently meetings and decisions the committee has made to influence treatments options in oncology.

During the 1st Annual Texas MPM Workshop, Aaron Gerds, MD, MS presented on the ruxolitinib in the present and future, as well as the possibilities for moving beyond the JAK-STAT pathway.

The FDA has granted approval to a generic form of the chemotherapy agent pemetrexed, which is indicated for intravenous administration in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer that have not progressed following 4 cycles of first-line platinum-based chemotherapy.

The FDA accepted a New Drug Application for tepotinib and granted it priority review for the treatment of adult patients with metastatic non–small cell lung cancer who harbor a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.

Treatment with tesetaxel in combination with capecitabine led to an improvement in progression-free survival as treatment of patients with metastatic breast cancer compared with single-agent capecitabine, meeting the primary end point of the phase 3 CONTESSA study.

During a debate at the 2020 Debates and Didactics in Hematology and Oncology Conference, Mehmet Akce, MD and Pretesh Patel, MD, argued their position on whether perioperative therapy for GEJ/gastric cancers should include radiation.

A supplemental New Drug Application was submitted to the FDA for cabozantinib plus nivolumab as treatment of patients with advanced renal cell carcinoma.

Progression-free survival was not improved with the combination of spartalizumab, dabrafenib, and trametinib when administered as treatment of untreated patients with unresectable or metastatic BRAF V600E-mutant cutaneous melanoma compared with dabrafenib plus trametinib alone, missing the primary end point of the phase 3 COMBI-I clinical trial.

The FDA granted approval to the combination of daratumumab plus carfilzomib and dexamethasone as treatment of adult patients with relapsed or refractory multiple myeloma who have received up to 3 prior lines of therapy.

In an interview with Targeted Oncology following the conference, Kevin Kalinsky, MD, MS, gave his take on how targeted therapies are impacting the field of HER2-positive metastatic breast cancer, and he interprets the primary data from the phase 2 HER2CLIMB trial.

The application of liquid biopsies is becoming more common in the field of non–small cell lung cancer as the utility of liquid biopsies in the detection of key biomarkers continues to be confirmed through clinical trials.