Jason M. Broderick

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of dacomitinib for the frontline treatment of adult patients with metastatic non–small cell lung cancer with EGFR-activating mutations.

A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab (Darzalex) for use in combination with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of certain patients with multiple myeloma.

The European Commission has approved blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.

The European Commission has approved nivolumab combined with low-dose ipilimumab as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.

The FDA has approved cabozantinib as a treatment for patients with hepatocellular carcinoma who previously received sorafenib.

The FDA has extended the review period for a supplemental biologics license application for single-agent pembrolizumab for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with a PD-L1 expression level of ≥1% and no EGFR or ALK genomic tumor aberrations.

The European Commission has approved pembrolizumab as an adjuvant treatment for patients with resected, stage III melanoma with lymph node involvement.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.

Durvalumab alone and in combination with tremelimumab did not improve overall survival versus standard-of-care chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed after platinum-based chemotherapy.

Ado-trastuzumab emtansine reduced the risk of invasive disease recurrence or death by 50% compared with trastuzumab as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy.

The FDA has granted a priority review designation to a supplemental biologics license application for atezolizumab for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.

The triplet of daratumumab, lenalidomide, and dexamethasone reduced the risk of disease progression or death by 44% compared with lenalidomide plus dexamethasone in newly diagnosed patients with multiple myeloma who were not candidates for high-dose chemotherapy and autologous stem-cell transplant.

The R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) reduced the risk of disease progression or death by 54% versus rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma.

The triplet regimen of pembrolizumab (Keytruda) plus umbralisib and ublituximab reached a 90% response rate in patients with relapsed/refractory chronic lymphocytic leukemia.

Treating younger patients with low-risk diffuse large B-cell lymphoma with 2 fewer frontline cycles of R-CHOP greatly reduced toxicity without sacrificing efficacy, according to findings from the FLYER trial.

Ibrutinib as monotherapy and combined with rituximab significantly improved progression-free survival compared with bendamustine plus rituximab as frontline therapy for older patients with chronic lymphocytic leukemia.

The FDA has approved gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia.

The FDA has approved larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors with an NTRK gene fusion.

The FDA has granted a priority review designation to a new drug application for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia.

The FDA has approved glasdegib for use in combination with low-dose cytarabine for the treatment of patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older or who are ineligible for intensive chemotherapy.

The FDA has granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

The novel bispecific antibody ZW25 induced a disease control rate of 82% in heavily pretreated patients across several HER2-positive tumor types, according to phase I study results presented at the 2018 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.

The frontline combination of durvalumab (Imfinzi) and tremelimumab did not induce a statistically significant improvement in overall survival compared to standard chemotherapy in patients with metastatic non–small cell lung cancer.

The FDA has approved brentuximab vedotin for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.

The FDA has granted brentuximab vedotin a breakthrough therapy designation for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.

The FDA has granted a priority review designation to a supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The FDA has granted a priority review designation to a supplemental new drug application for olaparib tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

The FDA has approved pembrolizumab for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib.

Treatment for cutaneous squamous cell carcinoma (CSCC) took a great leap forward in September 2018 with the PD-1 inhibitor cemiplimab becoming the first agent specifically approved by the FDA for advanced CSCC.