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“The results that we’ve seen do suggest that there is some interaction between the two drugs, despite ongoing debate of whether this regimen after progression on a PD-1 inhibitor could be beneficial in clear cell renal cell carcinoma."

"The acceptance of our submission for CC-486 represents an important step towards a potential new maintenance treatment to address an urgent medical need for patients with AML and we look forward to working with the FDA during its review of CC-486."

The electrical impedance spectroscopy system , Nevisense 3.0, a third-generation of the SciBase Nevisense system, for the early detection of melanoma has been granted FDA approval.

Here’s a look back on the FDA happenings from the month of April 2020.

“We believe these results, although anecdotal, are very impressive and the number of patients treated under eIND is rapidly increasing."

"As anticipated, the data continues to become more compelling with extended SGX301 treatment."

“The ATLANTIS trial reflects an exciting innovation in front-line precision cancer medicine for patients with advanced [urothelial cancer]."

"Over the last 12 years, an average of 9 practices per month have closed, been acquired by a hospital, or merged. These are troubling trends and dangerous for patients battling cancer...”

In an interview with Targeted Oncology, Elizabeth M. Swisher, MD, discussed data for PARP inhibitor maintenance therapy in patients with ovarian cancer, including the VELIA study of veliparib and the ARIEL3 trial of rucaparib.

In an interview with Targeted Oncology, Luca dos Santos, MD, MsC, discussed the combination of irinotecan plus cisplatin in comparison to gemcitabine and cisplatin as treatment of patients with metastatic or unresectable biliary tract cancer.

The FDA's Fast Track designation for second-line eryaspase as treatment of patients with metastatic pancreatic cancer underscores the need for new treatment options in this patient population.

A manageable safety profile was demonstrated with the combination of atezolizumab plus an anti-CD19 chimeric antigen receptor T-Cell therapy in patients with refractory diffuse large B-cell lymphoma in the ZUMA-6 trial.

A new dosage for pembrolizumab of 400 mg administered every 6 weeks across all adult indications has been approved by the FDA, whether the PD-1 inhibitor is used as monotherapy or in a combination regimen.

"The confirmation of the initial safety profile of NOX-A12 in combination with radiotherapy in all patients of the first cohort is very encouraging."

Deep and durable responses were observed in 97 patients with advanced non–small cell lung cancer harboring a MET exon 14 mutation with treatment of capmatinib, according to GEOMETRY mono-1 study, presented at the 2020 American Association for Cancer Research Annual Meeting.

Interim findings of the ongoing phase II ZENITH20 trial demonstrated that poziotinib induced a 68.7% disease control rate when used as treatment of patients with pretreated non–small cell lung cancer harboring an EGFR exon 20 insertion.

Few options exist for patients with relapsed or refractory large B-cell lymphomas who have already undergone 2 rounds of systemic therapy. New research shows axicabtagene ciloleucel might be a strong option, but community oncologists must play a role in patient identification and post-treatment follow-up.

"Because pacritinib inhibits JAK2, IRAK-1, and CSF1R, there is real potential for pacritinib to prevent patients from developing an inflammatory response to the coronavirus infection and subsequent pulmonary failure, therefore reducing the need for a ventilator."

High response rates were observed in patients with newly diagnosed multiple myeloma with induction treatment of bortezomib and lenalidomide plus dexamethasone after autologous stem cell transplant.

"While we are disappointed by the outcome of the VOYAGER trial, we are deeply grateful to the patients, investigators, and clinical site staff who contributed to the completion of this global study."

“Durvalumab and olaparib [given] concurrently with paclitaxel increased pCR rates in all 3 biomarker subsets where it was studied. The estimated probability that the experimental arm is superior to chemotherapy alone is greater than 98% in all subsets.”

“The PFS advantage in favor of continuous dosing was observed in younger and older patients, men and women, patients with and without prior immune checkpoint inhibitor therapy, and in patients with normal and elevated baseline LDH levels."

"This is the largest clinical trial evaluating a PD-1 inhibitor as a first-line monotherapy in patients with advanced non–small cell lung cancer with high PD-L1 expression. These positive results are extremely encouraging."

In an interview with Targeted Oncology, Thomas E. Stinchcombe, MD, professor, Medicine, Duke Cancer Institute, discussed resistance testing to aid treatment of patients with lung cancer. He also discussed the shift from tissue to liquid biopsy.

Mobocertinib was granted a Breakthrough Therapy designation by the FDA for the treatment of patients with metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

In an interview with Targeted Oncology, William Dale, MD, discussed his experience with caring for geriatric oncology patients during the COVID-19 pandemic. He also shared best practices for using telemedicine during this time.

"Our team has done an excellent job continuing to advance our clinical programs, operations and business objectives during the COVID-19 pandemic. March was one of the higher enrolling months in the SIERRA trial with multiple patients enrolled after the COVID-19 pandemic emerged in full force with active screening continuing."

“While we’re in very tough times, this crisis presents an opportunity to improve the quality and resiliency of cancer care. To maximize that potential, we’ll be drawing on the expertise of the full cancer community, action by policymakers, and data to proactively transition to post-crisis cancer care and achieve the best outcomes for patients in the months and years ahead.”

“Overall survival in metastatic castration-resistant prostate cancer has remained extremely challenging to achieve. We are thrilled by these results for Lynparza and we are working with regulatory authorities to bring this medicine to patients as soon as possible.”

"We are delighted to add the first FDA approval of this important companion diagnostic on Dako Omnis."