Jason M. Broderick

The FDA has granted a full approval to frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer.

The FDA has approved single-agent nivolumab for the treatment of patients with small cell lung cancer with disease progression following 2 or more lines of therapy.

The FDA has approved lenvatinib as a first-line treatment for patients with unresectable hepatocellular carcinoma.

The FDA has approved mogamulizumab for the treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy.

A rolling submission of an FDA new drug application has been completed for selinexor for the treatment of patients with penta-refractory multiple myeloma, according to Karyopharm Therapeutics.

The FDA has granted a breakthrough therapy designation to the combination of encorafenib (Braftovi), binimetinib (Mektovi), and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer.

The FDA has granted lurbinectedin (PM1183) an orphan drug designation for the treatment of patients with small cell lung cancer.

The FDA has granted a breakthrough therapy designation to the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) for the treatment of patients with advanced and/or metastatic non–microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after ≥1 prior systemic therapy.

The FDA has granted a breakthrough therapy designation to quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia.

The European Commission has approved nivolumab (Opdivo) as an adjuvant treatment for adult patients with completely resected melanoma with lymph node involvement or metastatic disease, regardless of BRAF mutation status.

The FDA has approved iobenguane I-131 (Azedra) for adult and pediatric patients aged ≥12 years with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab (Keytruda) for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed following platinum-based chemotherapy and have a PD-L1 tumor proportion score ≥50%.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of frontline pembrolizumab (Keytruda) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer without EGFR or ALK mutations, regardless of PD-L1 expression.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of durvalumab for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer who have not progressed following chemoradiotherapy and whose tumors express PD-L1 on ≥1% of tumor cells.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the combination of dabrafenib and trametinib for the adjuvant treatment of adult patients with BRAF V600E– or V600K–positive stage III melanoma following complete resection.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of daratumumab in combination with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the combination of the BRAF inhibitor encorafenib and the MEK inhibitor binimetinib for the treatment of adult patients with BRAF V600–mutant unresectable or metastatic melanoma.

The China National Drug Administration has approved pembrolizumab (Keytruda) for the treatment of adult patients with unresectable or metastatic melanoma after 1 prior line of therapy.

Brigatinib reduced the risk of disease progression or death versus crizotinib in adult patients with locally advanced or metastatic ALK-positive non–small cell lung cancer who had not received a prior ALK inhibitor.

Pembrolizumab (Keytruda) significantly improved overall survival compared with the standard frontline regimen of cetuximab (Erbitux) plus platinum chemotherapy and 5-FU in patients with recurrent or metastatic HNSCC.

Combining lenalidomide with rituximab significantly improved progression-free survival compared with rituximab alone for the treatment of patients with relapsed/refractory indolent lymphoma.

The FDA has approved ivosidenib for the treatment of adult patients with relapsed/refractory IDH1-mutant acute myeloid leukemia.

Adding atezolizumab to pemetrexed and cisplatin or carboplatin in the frontline setting reduced the risk of disease progression or death versus chemotherapy alone in patients with advanced nonsquamous non–small cell lung cancer, according to findings from the phase III IMpower132 study.

The FDA has granted atezolizumab a breakthrough therapy designation for use in combination with bevacizumab as a first-line treatment for patients with advanced or metastatic hepatocellular carcinoma.

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