Jason M. Broderick

Adding daratumumab to lenalidomide and dexamethasone reduced the risk of disease progression or death by 45% compared with lenalidomide/dexamethasone alone in newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant.

The FDA has granted a priority review designation to a supplemental new drug application for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.

Darolutamide significantly improved metastasis-free survival versus placebo in patients with nonmetastatic castration-resistant prostate cancer enrolled in the phase III ARAMIS trial.

The FDA has added 3 months to the review period for the combination of nivolumab plus low-dose ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.

A new drug application has been submitted to Japan's Ministry of Health, Labor and Welfare for quizartinib for the treatment of adult patients with FLT3-ITD–positive acute myeloid leukemia.

The FDA has granted a priority designation to a supplemental new drug application for ibrutinib for use in combination with obinutuzumab for the frontline treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 recommending approval of the rituximab biosimilar CT-P10 for 3 non-Hodgkin lymphoma indications.

Combining brentuximab vedotin with frontline chemotherapy led to a statistically significant improvement in progression-free and overall survival in patients with CD30-expressing peripheral T-cell lymphoma, according to topline results from the phase III ECHELON-2 trial.

The FDA has approved a once-weekly dosing option of carfilzomib to use in combination with dexamethasone for patients with relapsed/refractory multiple myeloma.

The FDA has approved the PD-1 inhibitor cemiplimab (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation.

The FDA has approved dacomitinib (Vizimpro) for the frontline treatment of patients with metastatic non–small cell lung cancer with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

The FDA has approved duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory follicular lymphoma.

The European Commission has approved the combination of encorafenib (Braftovi) and binimetinib (Mektovi) for the treatment of adult patients with BRAF V600–mutant unresectable or metastatic melanoma.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for October 10, 2018, to discuss a biologics license application for CT-P10, a proposed biosimilar to rituximab.

The FDA has added minimal residual disease data from the phase III MURANO trial to the label for venetoclax for its approved use in combination with rituximab for previously-treated patients with chronic lymphocytic leukemia.

Combining the PD-L1 inhibitor avelumab with the VEGF inhibitor axitinib significantly improved progression-free survival compared with sunitinib in treatment-naïve patients with advanced renal cell carcinoma, according to findings from the phase III JAVELIN Renal 101 study.

The European Commission has approved frontline pembrolizumab for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer without EGFR or ALK mutations.

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma.

The European Commission has approved daratumumab for use in combination with bortezomib, melphalan, and prednisone (VMP) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The FDA has accepted a supplemental biologics license application for dasatinib for use in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

The European Commission has approved the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) for the adjuvant treatment of patients with BRAF V600–positive stage III melanoma.

The European Commission has approved blinatumomab for the treatment of pediatric patients with Philadelphia chromosome–negative, CD19-positive B-cell precursor acute lymphoblastic leukemia that is refractory or in relapse after receiving at least 2 prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

The European Commission has approved 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 Commission has approved CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related acute myeloid leukemia or AML with myelodysplasia-related changes.

The European Commission has approved tisagenlecleucel (Kymriah) for the treatment of either adult patients with relapsed/refractory diffuse large B-cell lymphoma, or patients up to 25 years of age with relapsed B-cell acute lymphoblastic leukemia.

The FDA has approved ibrutinib in combination with rituximab for the treatment of patients with Waldenström macroglobulinemia.

The European Commission has approved lenvatinib (Lenvima) as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma.

The FDA has granted a priority review to a supplemental biologics license application for elotuzumab for use in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.

The Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved osimertinib for the frontline treatment of patients with inoperable or recurrent EGFR-positive non–small cell lung cancer.

The China National Drug Administration has approved alectinib for the treatment of patients with ALK-positive, advanced non–small cell lung cancer.