Jason M. Broderick

The FDA has granted a priority review designation to a supplemental new drug application for tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.

The FDA has granted a priority review designation to a new drug application for cedazuridine plus decitabine for the treatment of adult patients with previously untreated intermediate- and high-risk myelodysplastic syndromes or chronic myelomonocytic leukemia.

The FDA has granted a priority review designation to a new drug application for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, following at least 3 prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant, or metastatic setting.

The FDA has granted a priority review designation to a new drug application for ripretinib for the treatment of patients with advanced gastrointestinal stromal tumors.

A supplemental Biologics License Application has been submitted to the FDA for daratumumab for use in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma.

The FDA has granted a priority review designation to a new drug application for capmatinib for use as treatment for newly diagnosed and previously treated patients with locally advanced or metastatic MET exon14 skipping—mutated non–small cell lung cancer.

The European Commission has approved apalutamide for use in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer.

Trastuzumab deruxtecan (Enhertu) improved overall survival versus chemotherapy in patients with heavily pretreated unresectable or metastatic HER2-positive gastric or gastroesophageal junction cancer.

A new drug application has been submitted to the FDA for tucatinib for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

A biologics license application has been submitted to the FDA for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer.

The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine.

The FDA’s Oncologic Drugs Advisory Committee voted in support of approving pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

A biologics license application has been filed with the FDA for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

A new drug application has been submitted to the FDA seeking an accelerated approval for lurbinectedin for use as a second-line treatment for patients with small cell lung cancer.

Mathematical modeling was unable to harmonize the VENTANA SP263 and Dako 22C3 PD-L1 assays with the FDA-approved VENTANA PD-L1 SP142 companion diagnostic for the selection of patients with advanced triple-negative breast cancer appropriate for atezolizumab plus nab-paclitaxel.

Adding the PARP inhibitor olaparib to neoadjuvant platinum based-chemotherapy was determined to be a safe treatment for patients with triple-negative breast cancer, as well as for patients with breast cancer whose tumors harbor germline BRCA mutations.

The invasive disease-free survival benefit with adjuvant T-DM1 versus trastuzumab in patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy was observed regardless of the type of neoadjuvant chemotherapy used.

A durvalumab-based neoadjuvant regimen induced an impressive pathologic complete response rate in patients with triple-negative breast cancer.

Olaparib continued to show a numerical overall survival (OS) benefit with a favorable hazard ratio for OS versus chemotherapy in patients with BRCA-positive, HER2-negative metastatic breast cancer, according to an extended, exploratory follow-up analysis of the phase III OlympiAD trial.

Maintenance durvalumab may improve outcomes versus chemotherapy in patients with triple-negative breast cancer or those with PD-L1–positive breast cancer across several subtypes, according to exploratory analyses from the phase II randomized SAFIR02-IMMUNO trial presented at the 2019 San Antonio Breast Cancer Symposium.

Real-world data for frontline palbociclib indicate that the positive progression-free survival data observed with the CDK4/6 inhibitor in the pivotal PALOMA-2 trial would likely translate to an overall survival benefit in patients with HR-positive/HER2-negative metastatic breast cancer

Margetuximab continued to show a clear progression-free survival benefit and a trend toward an overall survival benefit versus trastuzumab (Herceptin) when either agent was combined with chemotherapy in patients with HER2-positive metastatic breast cancer who had received prior anti-HER2 therapies.

Adding tucatinib to trastuzumab (Herceptin) and capecitabine (Xeloda) reduced the risk of death by 34% in heavily pretreated patients with unresectable locally advanced or metastatic HER2-positive breast cancer.

Adding daratumumab (Darzalex) to carfilzomib (Kyprolis) and dexamethasone reduced the risk of disease progression or death by 37% compared with carfilzomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma.

The BCMA-directed CAR T-cell therapy JNJ-4528 achieved a 100% overall response rate with early and deep responses in 29 patients with heavily pretreated relapsed/refractory myeloma.

The FDA’s Oncologic Drugs Advisory Committee will not be reviewing an sBLA for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes.

The FDA’s Oncologic Drugs Advisory Committee has scheduled a hearing to review a supplemental Biologics License Application for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes.

The FDA has granted a priority review designation to a supplemental Biologics License Application for durvalumab for the frontline treatment of patients with extensive-stage small cell lung cancer.

The frontline combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) reduced the risk of disease progression or death by 42% compared with sorafenib (Nexavar) in patients with unresectable hepatocellular carcinoma.

The FDA has approved acalabrutinib for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.