Jason M. Broderick

The FDA has granted a priority review designation to a biologics license application for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer following at least 2 prior therapies for metastatic disease.

A rolling submission of an FDA new drug application (NDA) has been submitted for selinexor for the treatment of patients with penta-refractory multiple myeloma.

The FDA has approved upfront ribociclib for use in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer. The agency also approved the CDK 4/6 inhibitor for use in combination with fulvestrant for the treatment of postmenopausal women with HR-positive/HER2-negative advanced or metastatic breast cancer, in the frontline setting or after disease progression on endocrine therapy.

The FDA has approved enzalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

A supplemental New Drug Application has been submitted to the FDA for venetoclax (Venclexta) for use in combination with a hypomethylating agent or low-dose cytarabine for the first-line treatment of patients with acute myeloid leukemia.

The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab for previously treated patients with advanced hepatocellular carcinoma

Combining ibrutinib with standard R-CHOP did not improve event-free survival versus R-CHOP alone in the first-line setting for patients with diffuse large B-cell lymphoma.

Ixazomib (Ninlaro) improved progression-free survival compared with placebo as a maintenance therapy in adult patients with multiple myeloma who responded to high-dose therapy and autologous stem cell transplant.

The FDA has approved the combination of nivolumab and ipilimumab for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

Combining pixantrone (Pixuvri) with rituximab (Rituxan) failed to improve progression-free survival compared with gemcitabine plus rituximab in patients with aggressive B-cell non-Hodgkin lymphoma.

The European Commission has approved dasatinib for the treatment of children and adolescent patients aged 1 to 18 years with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase.

A de-escalated, chemotherapy-free neoadjuvant regimen of letrozole plus dual HER2 blockade showed promise in patients with HER2+/HR+ breast cancer who first achieved a molecular response to 2 weeks of letrozole.

Upfront treatment with atezolizumab plus nab-paclitaxel significantly reduced the risk of disease progression or death compared with nab-paclitaxel alone in patients with metastatic or unresectable locally advanced triple-negative breast cancer.

The FDA has granted a priority review designation to a supplemental biologics license application for first-line pembrolizumab for use in combination with carboplatin/paclitaxel or nab-paclitaxel for the treatment of patients with metastatic squamous non–small cell lung cancer, regardless of PD-L1 expression.

The European Medicines Agency’s CHMP has recommended approval of axicabtagene ciloleucel (axi-cel; Yescarta) as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of CPX-351, a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab (Opdivo) as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of tisagenlecleucel for the treatment of either adult patients with diffuse large B-cell lymphoma that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia that is refractory, in relapse posttransplant, or in second or later relapse.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of neratinib for the extended adjuvant treatment of adult patients with early stage hormone receptor–positive, HER2-overexpressed/amplified breast cancer following postoperative trastuzumab.

European patients with non-Hodgkin lymphoma are more likely to be prescribed a rituximab biosimilar if they are in better overall health, have indolent histology, and have follicular lymphoma.

The FDA has granted a priority review to a new drug application for glasdegib for use in combination with chemotherapy for the frontline treatment of patients with acute myeloid leukemia.

The FDA has approved the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK inhibitor binimetinib (Mektovi) for the treatment of patients with BRAF-mutant unresectable or metastatic melanoma, as detected by an FDA-approved test.

Olaparib tablets reduced the risk of disease progression or death compared with placebo as frontline maintenance therapy for women with BRCA-positive advanced ovarian cancer, according to findings from the randomized phase III SOLO-1 trial.

Combining frontline atezolizumab with chemotherapy improved overall survival and progression-free survival compared with chemotherapy alone in patients with extensive-stage small cell lung cancer.

The FDA has accepted a supplemental biologics license application for the use of pembrolizumab as an adjuvant treatment for patients with resected, high-risk stage III melanoma.

The FDA has granted a priority review to a supplemental new drug application for ibrutinib for use in combination with rituximab as a treatment option across all lines of therapy for patients with Waldenström macroglobulinemia.

Ruxolitinib combined with corticosteroids induced an overall response rate of 55% at day 28 in patients with steroid-refractory acute graft-versus-host disease, meeting the primary endpoint of the phase II REACH1 trial.

The European Commission has granted blinatumomab full marketing authorization for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.

The FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or those who have relapsed after 2 or more prior lines of therapy.

The FDA has approved bevacizumab for use in combination with carboplatin and paclitaxel, followed by bevacizumab monotherapy, for the treatment of women with advanced ovarian cancer following initial surgical resection.