Gina Columbus

The European Medicine Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion to olaparib tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.

Mirvetuximab soravtansine did not improve progression-free survival compared with chemotherapy in patients with folate receptor alpha–positive, platinum-resistant ovarian cancer and in an overall patient population, missing the primary endpoint of the phase III FORWARD I trial.

The FDA has expanded the approval of aprepitant injectable emulsion to include a 2-minute intravenous use for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.

The FDA has approved subcutaneous use of trastuzumab and hyaluronidase-oysk injection in combination with chemotherapy for the treatment of select patients with HER2-positive early breast cancer, in combination with paclitaxel in patients with metastatic HER2-positive breast cancer as a frontline treatment, and alone for patients with metastatic disease who have received at least 1 prior chemotherapy regimen

Leo I. Gordon, MD, discussed these recent updates in Hodgkin lymphoma and non–Hodgkin lymphoma and pointed to research on the horizon.

The combination of pembrolizumab plus best supportive care for the treatment of patients with advanced hepatocellular carcinoma who were previously treated with systemic therapy did not improve progression-free or overall survival compared with placebo plus best supportive care alone, missing the coprimary endpoints of the KEYNOTE-240 trial.

The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab (Keytruda) as a treatment for patients with advanced small cell lung cancer whose disease has progressed following ≥2 prior lines of therapy.

Suman Kambhampati, MD, reflects on the emergence of data in chronic lymphocytic leukemia from the 2018 ASH Annual Meeting.

The FDA has granted a priority review designation to a new drug application for entrectinib as a treatment for select adult and pediatric patients with NTRK fusion–positive locally advanced or metastatic solid tumors, as well as patients with metastatic ROS1-positive non–small cell lung cancer.

The FDA has approved the PD-1 inhibitor pembrolizumab for the adjuvant treatment of patients with high-risk stage III melanoma with lymph node involvement following complete resection.

Theresa Shao, MD, discusses the neoadjuvant and adjuvant findings with pertuzumab as well as the adjuvant use of neratinib in patients with locally advanced HER2-positive breast cancer.

The FDA has granted a priority review designation to a supplemental biologics license application for the combination of pembrolizumab and axitinib as a frontline treatment for patients with advanced renal cell carcinoma.

The FDA has approved a split-dosing regimen of daratumumab for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session.

The FDA has granted a priority review designation to a supplemental biologics license application for the combination of avelumab and axitinib as a treatment for patients with advanced renal cell carcinoma.

The combination of pembrolizumab (Keytruda) and axitinib (Inlyta) was associated with a significantly longer progression-free and overall survival compared with sunitinib (Sutent) in treatment-naïve patients with clear cell metastatic renal cell carcinoma.

The FDA has granted a priority review designation to a supplemental biologics license application for pembrolizumab (Keytruda) alone or in combination with platinum and 5-fluorouracil chemotherapy as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

The European Commission has approved dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for February 26, 2019, to discuss a new drug application for selinexor in combination with dexamethasone for the treatment of patients with penta-refractory multiple myeloma.

Erika P. Hamilton, MD, reflects on the latest data in HER2-positive breast cancer and additional therapies moving through the pipeline.

Margetuximab in combination with chemotherapy improved progression-free survival compared with trastuzumab and chemotherapy in heavily pretreated patients with metastatic HER2-positive breast cancer.

The FDA has approved the nanobody caplacizumab-yhdp in combination with plasma exchange and immunosuppression for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura, making it the first FDA-approved therapy indicated for this patient population.

Komal Jhaveri, MD, discusses the 3 major classes of drugs showing potential in the TNBC pipeline.

The FDA has granted a priority review designation to a new drug application for the investigational, small molecule, CSF1R receptor inhibitor pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.

Isatuximab in combination with pomalidomide (Pomalyst) and low-dose dexamethasone was shown to prolong progression-free survival compared with pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Rachna T. Shroff, MD, MS, highlighted the ongoing research efforts in biliary tract cancers, specifically with cholangiocarcinoma treatment.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for first-line treatment with pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel in patients with metastatic squamous non–small cell lung cancer.

Denise A. Yardley, MD, discusses key data presented at the 2018 SABCS and the impact of the SOLAR-1 findings.

The European Medicine’s Agency Committee for Medicinal Products for Human Use has recommended approval for the frontline combination of atezolizumab, bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer.

Howard A. “Skip” Burris, MD, highlights some of the exciting updates from the 2018 San Antonio Breast Cancer Symposium and what can be expected in the breast cancer field in the year ahead.

The UK’s National Institute for Health and Care Excellence has authorized the use of the CAR T-cell therapy tisagenlecleucel (Kymriah) for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma who have received ≥2 lines of chemotherapy.