Nichole Tucker

Atezolizumab has received its fifth indication in NSCLC as treatment of adult patients with metastatic non–small cell lung cancer who have high PD-L1 expression.

A study found correlation between body mass index in patients with non–small cell lung cancer treated with atezolizumab and improved survival outcomes.

Positive safety and efficacy outcomes were witnessed in the KEYNOTE-365 study , supporting further assessment of the combination of pembrolizumab and enzalutamide in a larger population of patients with metastatic castration resistance prostate cancer.

Pomalidomide is now FDA approved for treatment of Kaposi sarcoma under multiple indications.

The New Drug Application for avapritinib as treatment of unresectable or metastatic fourth-line gastrointestinal stromal tumor was refused by the FDA, according to a recently issued complete response letter.

"...These results leave us increasingly confident that ADXS-503 has the potential to restore or enhance sensitivity to checkpoint inhibitors..."

In an interview with Targeted Oncology, Verstovsek, medical oncologist and professor, Department of Leukemia, University of Texas MD Anderson Cancer Center, discussed mutational profiling for myelofibrosis and how the information obtained can be valuable for clinical management of the disease.

The review of the Biologics License Application for idecabtagene vicleucel has been put on hold. The FDA issued a Refusal to File letter due to the need for additional data from the developer of the drug.

"Targeting PD-1/PD-L1 may provide a much-needed treatment option for patients with PDL1–positive advanced ATC."

"This is the second positive phase 3 trial for Sarclisa, further supporting the potential our medicine has to improve outcomes for patients struggling with relapsed multiple myeloma.”

In an interview with Targeted Oncology, Erica Mayer, MD, discussed advances in the treatment landscape of HR-positive, HER2-negative breast, primarily with endocrine therapy and CDK4/6 inhibition.

Trastuzumab deruxtecan received Breakthrough Therapy Designation for the treatment of patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

"HER2-targeted therapy has changed the natural history of HER2-positive metastatic breast cancer, with the dual blockade of pertuzumab and trastuzumab, with docetaxel, demonstrating an 8-year landmark overall survival rate of 37%."

"Combining pembrolizumab with Tavo electroporation improved responses for these patients who were predicted to have very poor responses to single-agent immune checkpoint inhibition."

The FDA granted approval to the combination of olaparib and bevacizumab for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with bevacizumab and whose cancer is associated with homologous recombination deficiency–positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability.

"We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to-treat disease."

Administering endoxifen in the window of opportunity between diagnosis and treatment may be effective for reducing tumor activity in patients with breast cancer.

"The emergence of the anti-PD-1 antibody has brought a new treatment modality for patients with squamous NSCLC."

"Mesothelioma remains a challenging disease with generally poor prognosis, and there is a large unmet medical need for new, innovative treatments such as ONCOS-102..."

"Having obtained an encouraging proof-of-concept for the liver-cancer directed effect of MIV-818 in phase Ia, we hope to get additional supportive data from the phase Ib study. We believe that MIV-818 has the potential to provide liver cancer patients with major therapeutic benefits."

The FDA extended the Prescription Drug User Fee Act target action date for liso-cel due to the submission of additional information by the drug developer, which will require additional time to review.

Results from the phase Ib/II study of VERU-111 in patients with metastatic castration-resistant prostate cancer have prompted plans to meet with the FDA in the third quarter of 2020 to discuss the trial design for a phase III clinical trial of VERU-111 for this indication.

"...These important new results further demonstrate Libtayo’s potential in patients with difficult-to-treat, non-melanoma skin cancers."

A safety, tolerability, pharmacokinetics, and preliminary efficacy of avadomide in patients with advanced solid tumors, non-Hodgkin lymphomas, or multiple myeloma shows evidence of preliminary activity. Findings from the diffuse large B-cell cohort were published in Blood.

In an interview with Targeted Oncology, Gregory L. Beatty, MD, PhD, discussed the science behind the development of metastases in pancreatic tumors, including how metastases differ in various sites in the body. He also reviewed the treatment options for this disease.

In an interview with Targeted Oncology, Sarat Chandarlapaty, MD, PhD, explained the mechanisms of resistance to CDK4/6 inhibitors. He also discussed new therapeutic strategies are being curated and implemented to overcome resistance in patients with ER-positive breast cancer.

“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."

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

"This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance."

"Single-agent trametinib had low rates of clinical activity in patients with heavily pretreated, metastatic cancers harboring non-V600 mutations in BRAF. This contrasts with a number of case reports, largely in melanoma, showing responses in patients with these mutations."