Jason M. Broderick

The FDA has granted enfortumab vedotin a breakthrough therapy designation for patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint therapy.

Treatment with the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel significantly improved overall survival compared with bevacizumab and chemotherapy alone for patients with advanced nonsquamous non–small cell lung cancer.

The FDA has approved nilotinib for the first- and second-line treatment of pediatric patients aged 1 year and older with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase.

The FDA has approved brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma.

The addition of atezolizumab to frontline carboplatin and nab-paclitaxel delayed progression or death compared with chemotherapy alone for patients with advanced squamous non–small cell lung cancer.

Acquired HER2 mutations cause endocrine resistance in some patients with ER+/HER2-negative breast cancer.

The discovery of crosstalk between the HER2 and hormone receptor pathways has led to the promising treatment strategy of dual targeting regimens.

Several new agents have emerged in HER2-positive breast cancer with the potential to further alter the natural course of the disease.

The progression-free survival benefit for ribociclib in pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer was sustained across patient subgroups, according to findings from the phase III MONALEESA-7 trial.

The FDA has approved a supplemental biologics license application adding a 4-week dosing schedule for nivolumab across several of the PD-1 inhibitor’s indications.

The FDA has approved abemaciclib for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of gemtuzumab ozogamicin for use in combination with daunorubicin and cytarabine as a frontline treatment for patients aged 15 years and older with previously untreated, de novo CD33-positive acute myeloid leukemia, except acute promyelocytic leukemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against approving sunitinib for use as an adjuvant therapy in patients with renal cell carcinoma who have received nephrectomy and are high risk for recurrence.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of bosutinib (Bosulif) as a first-line treatment for patients with Philadelphia chromosome-positive chronic myeloid leukemia.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The FDA has approved durvalumab for the treatment of patients with locally advanced, unresectable stage III non–small cell lung cancer who have not progressed following chemoradiotherapy.

The FDA has approved apalutamide (Erleada) for the treatment of patients with nonmetastatic castration-resistant prostate cancer.

A new drug application has been submitted to the FDA for duvelisib for a full approval for relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval in relapsed/refractory follicular lymphoma.

Adding pomalidomide to the combination of bortezomib and low-dose dexamethasone led to a significant improvement in progression-free survival in patients with relapsed/refractory myeloma with prior exposure to lenalidomide.

Treatment with encorafenib and binimetinib improved survival versus single-agent vemurafenib (Zelboraf) in patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

Apalutamide (ARN-509) reduced the risk of metastasis or death by 72% in patients with nonmetastatic castration-resistant prostate cancer, according to findings from the phase III SPARTAN trial.

The FDA has approved Lutathera for the treatment of patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

The FDA has approved a supplemental new drug application that adds overall survival data from the phase III ENDEAVOR trial to the label for carfilzomib for use in patients with relapsed or refractory multiple myeloma.

The FDA has granted a priority review to the CAR T-cell therapy tisagenlecleucel for adult patients with relapsed/refractory DLBCL who are ineligible for or relapse after autologous stem cell transplant.

Combining pembrolizumab with chemotherapy in the frontline setting improved survival in patients with nonsquamous non–small cell lung cancer.

The combination of the CAR T-cell therapy axicabtagene ciloleucel and the PD-L1 inhibitor atezolizumab was highly active with a manageable safety profile in patients with refractory DLBCL enrolled in the phase I/II ZUMA-6 trial.

The FDA approved the PARP inhibitor olaparib (Lynparza) for the treatment of patients with germline BRCA-positive, HER2-negative metastatic breast cancer.

The FDA has granted the combination of the PD-1 inhibitor pembrolizumab and the VEGF/FGF inhibitor lenvatinib a breakthrough therapy designation for the treatment of patients with advanced and/or metastatic renal cell carcinoma.

Adjuvant pembrolizumab reduced the risk of recurrence by 43% in patients with stage III resected high-risk melanoma.

The FDA has approved denosumab (Xgeva) for the prevention of skeletal-related events in patients with multiple myeloma.