Jason M. Broderick

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab (Keytruda) in combination with axitinib (Inlyta) for the frontline treatment of patients with advanced renal cell carcinoma.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approving elotuzumab (Empliciti) for use in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of larotrectinib for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of TAS-102 for the treatment of adult patients with metastatic gastric cancer, including adenocarcinoma of the gastroesophageal junction, following treatment with at least 2 prior systemic regimens for advanced disease.

Erdafitinib induced an objective response rate of 40% in previously treated patients with locally advanced or metastatic urothelial carcinoma, according to findings from the pivotal phase II BLC2001 trial published in the New England Journal of Medicine.

The FDA has granted a priority review to tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

The CAR T-Cell therapy MB-102 has been granted an Orphan Drug Designation by the FDA, according to Mustang Bio, Inc, the manufacturer of the investigational treatment.

The FDA has accepted an application for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma.

The European Commission approved cemiplimab (Libtayo) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

An application has been submitted to the FDA for neratinib for use in combination with capecitabine for the third-line treatment of patients with HER2-positive metastatic breast cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the frontline combination of atezolizumab (Tecentriq) plus nab-paclitaxel (Abraxane) for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The FDA has issued a complete response letter to Daiichi Sankyo informing the company that its new drug application would not be approved for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia.

Combining telaglenastat (CB-839) with everolimus (Afinitor) doubled the median progression-free survival versus everolimus alone in heavily pretreated patients with advanced renal cell carcinoma.

Entrectinib received its first regulatory approval, as Japan’s Ministry of Health, Labour and Welfare has approved the drug for the treatment of adult and pediatric patients with NTRK fusion–positive, advanced recurrent solid tumors.

The FDA has granted an accelerated approval to polatuzumab vedotin (Polivy) for use in combination with bendamustine and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.

Neratinib combined with capecitabine reduced the risk of disease progression or death by 24% compared with lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer who received at least 2 prior lines of HER2-targeted therapy.

The PARP inhibitor olaparib reduced the risk of disease progression or death by 38% versus chemotherapy in patients with platinum-sensitive, relapsed, germline BRCA1/2-mutated ovarian cancer who received at least 2 prior lines of chemotherapy.

The investigational KRASG12C inhibitor AMG 510 achieved a 50% response rate in patients with KRASG12C-positive advanced non–small cell lung cancer, according to results from a phase I study presented at the 2019 ASCO Annual Meeting.

Adding ramucirumab to erlotinib reduced the risk of disease progression or death by over 40% versus erlotinib alone as a frontline treatment for patients with EGFR-positive NSCLC.

Adding isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death compared with pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Lurbinectedin monotherapy achieved an overall response rate of 35.2% as a second-line treatment for patients with small cell lung cancer, according to findings from a phase II basket trial presented at the 2019 ASCO Annual Meeting.

Adding apalutamide to androgen deprivation therapy (ADT) reduced the risk of the death by 33% in patients with metastatic castration-sensitive prostate cancer compared with ADT alone.

The FDA has granted a priority review designation to a supplemental biologics license application for daratumumab in combination with bortezomib, thalidomide, and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

A new drug application has been submitted to the FDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

The FDA has granted copanlisib (Aliqopa) a breakthrough therapy designation for the treatment of adult patients with relapsed marginal zone lymphoma who have received at least 2 prior therapies.

The FDA has approved the R2 regimen of lenalidomide plus rituximab for use in patients with previously treated follicular lymphoma and marginal zone lymphoma.

The FDA has approved the PI3K inhibitor alpelisib (Piqray) for the treatment of postmenopausal women, and men, with HR-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

The FDA has granted a breakthrough therapy designation to the tumor-infiltrating lymphocyte therapy LN-145 for the treatment of patients with recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy.

Entrectinib induced objective responses in 100% of pediatric patients with tumors harboring NTRK1/2/3, ROS1, or ALK gene fusions or mutations.

The FDA has approved the combination of venetoclax and obinutuzumab for the frontline treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.