Jason M. Broderick

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab as a monotherapy or in combination with platinum and 5-FU as frontline treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression on their tumors.

The FDA has approved a supplemental Biologics License Application for romiplostim, updating its label to include data demonstrating sustained platelet responses in adults with immune thrombocytopenia. Romiplostim is approved for the treatment of adult patients with newly diagnosed or persistent who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of daratumumab for use in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

The FDA has granted a priority review designation to a biologics license application for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer.

Combining the pegylated IL-10 pegilodecakin with FOLFOX (folinic acid, 5-FU, oxaliplatin) chemotherapy did not improve overall survival as a second-line therapy for patients with metastatic pancreatic cancer.

The European Commission has approved larotrectinib for the treatment of certain adult and pediatric patients with solid tumors who have an NTRK gene fusion without a known acquired resistance mutation.

Adding daratumumab to carfilzomib and dexamethasone improved progression-free survival in patients with relapsed/refractory multiple myeloma, according to topline findings from the phase III CANDOR study.

The FDA is updating the prescribing information and Patient Package Insert for CDK4/6 inhibitors to include a warning that the treatments in rare cases may cause severe inflammation of the lungs.

Liposomal irinotecan achieved disease control in almost half of patients as a second-line treatment for small cell lung cancer, according to findings from Part 1 of the phase II/III RESILIENT trial presented at the 2019 World Conference on Lung Cancer.

Single-agent atezolizumab extended overall survival compared with chemotherapy as a frontline treatment for patients with advanced nonsquamous and squamous non–small cell lung cancer and high PD-L1 expression, according to topline findings from the phase III IMpower110 trial.

The FDA has accepted a supplemental new drug application for neratinib for use in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed at least 2 prior lines of HER2-directed treatments.

The addition of atezolizumab (Tecentriq) to carboplatin and nab-paclitaxel (Abraxane) showed a clinical overall survival benefit among a subgroup of patients with advanced squamous non–small cell lung cancer.

The European Commission has approved atezolizumab for use in combination with carboplatin and nab-paclitaxel for the first-line treatment of adult patients with advanced, nonsquamous non–small cell lung cancer.

The European Commission has approved atezolizumab for use in combination with carboplatin and etoposide for the frontline treatment of adult patients with extensive-stage small cell lung cancer, according to Roche (Genentech) the developer of the PD-L1 inhibitor.

China’s National Medical Products Administration has approved osimertinib for the frontline treatment of adult patients with locally-advanced or metastatic non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 (L858R) substitutions.

The FDA has extended the review period for a supplemental biologics license application for atezolizumab for use in combination with carboplatin and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer who do not have EGFR or ALK aberrations.

AbbVie has officially ended its rovalpituzumab tesirine (Rova-T) research and development program, which was exploring the antibody-drug conjugate in patients with small cell lung cancer.

The European Commission has approved the frontline combination of atezolizumab plus nab-paclitaxel for the treatment of adult patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer, according to Roche (Genentech), the manufacturer of the PD-L1 inhibitor.

The European Commission has approved 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 FDA is hoping to improve the armamentarium for male patients with breast cancer through the issuance of industry guidelines aimed at encouraging the inclusion of male patients in breast cancer clinical trials.

The Japanese Ministry of Health, Labour and Welfare has approved TAS-102 (trifluridine/tipiracil; Lonsurf) for the treatment of patients with unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy.

Combining pyrotinib with capecitabine reduced the risk of disease progression or death by 64% compared with lapatinib (Tykerb) plus capecitabine in Chinese patients with relapsed or metastatic HER2-positive breast cancer.

The Japanese Ministry of Health, Labor and Welfare has approved daratumumab for use in combination with bortezomib, melphalan, and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Combining the PARP inhibitor olaparib (Lynparza) with temozolomide (Temodar) led to an overall response rate of 41.7% in patients with relapsed small cell lung cancer.

Combining olaparib with standard bevacizumab significantly improved progression-free survival compared with bevacizumab alone as frontline maintenance therapy in women with advanced ovarian cancer, regardless of BRCA status, according to topline results from the phase III PAOLA-1 trial.

Frontline osimertinib significantly improved overall survival compared with erlotinib or gefitinib in patients with EGFR-positive local advanced or metastatic non–small cell lung cancer, according to results from the phase III FLAURA trial.

The UK’s National Institute for Health and Care Excellence has authorized the use of pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the treatment of patients with metastatic squamous non–small cell lung cancer.

The combination of encequidar and oral paclitaxel improved the overall response rate compared with IV paclitaxel in patients with metastatic breast cancer.

Adding atezolizumab to platinum-based chemotherapy significantly improved progression-free survival in patients with previously untreated locally advanced or metastatic urothelial carcinoma, according to results from the phase III IMvigor130 study.

Adding the CDK4/6 inhibitor ribociclib to fulvestrant significantly improved overall survival as a first- or second-line treatment for postmenopausal women with hormone receptor–positive/HER2-negative breast cancer, according to findings from a preplanned interim analysis of the phase III MONALEESA-3 trial.