Gina Columbus

The European Commission has approved nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph nodes or metastatic disease who have undergone complete resection.

In an effort to improve colorectal cancer screening rates via a less invasive method, the registrational ECLIPSE is evaluating the performance of the LUNAR-2 blood test in detecting colorectal cancer in average-risk adults.

The combination of margetuximab and chemotherapy induced a 1.8-month median overall survival increase in patients with pretreated HER2-positive metastatic breast cancer compared with trastuzumab (Herceptin) and chemotherapy.

The FDA has approved niraparib (Zejula) for the treatment of patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and whose cancer is associated with homologous recombination deficiency–positive status.

The FDA has issued a draft guidance to propose labeling recommendations, including a boxed warning, to breast implant manufacturers in an effort to help patients understand the benefits and risks of these devices.

The FDA has expanded the approval of aprepitant (Cinvanti) injectable emulsion for intravenous use to include the 130-mg single-dose regimen for patients receiving moderately epigenetic chemotherapy.

The first-line combination of nivolumab (Opdivo) plus low-dose ipilimumab (Yervoy) given concomitantly with 2 cycles of chemotherapy showed superior overall survival compared with up to 4 cycles of chemotherapy alone followed by optional maintenance treatment in patients with advanced non–small cell lung cancer.

Tucatinib combined with trastuzumab and capecitabine improved overall survival and progression-free survival compared with trastuzumab/capecitabine alone in heavily pretreated patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

The combination of atezolizumab and bevacizumab showed statistically significant and clinically meaningful improvements in both progression-free and overall survival compared with sorafenib in patients with unresectable hepatocellular carcinoma who have not received prior therapy, meeting the coprimary endpoints of the IMbrave150 trial.

Findings from the 2019 ESMO Congress showcased that biosimilars for pegfilgrastim, filgrastim, bevacizumab, and trastuzumab demonstrated efficacy and safety equivalency with their reference counterparts in a number of malignancies.

The UK’s National Institute for Health and Care Excellence has approved rucaparib for the maintenance treatment of patients with relapsed ovarian, fallopian tube, or peritoneal cancer that has responded to platinum-based chemotherapy.

The FDA has awarded 12 new research grants that together total more than $15 million, to enhance the development of medical products for patients with rare diseases, including acute myeloid leukemia and gastrointestinal stromal tumor, among others.

The combination of ramucirumab and erlotinib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus erlotinib alone in treatment-naïve patients with EGFR-mutant non–small cell lung cancer, according to results of the phase III RELAY trial that have now been published in The Lancet Oncology.

The FDA has granted a breakthrough therapy designation to the PARP inhibitor niraparib for the treatment of patients with BRCA1/2–mutant metastatic castration-resistant prostate cancer who have previously received chemotherapy and an androgen receptor inhibitor.

The FDA has approved a labeling supplement for neratinib for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer.

Pembrolizumab (Keytruda) did not show an improvement in progression-free survival compared with chemotherapy in patients with malignant pleural mesothelioma.

The first-line combination of atezolizumab (Tecentriq) and chemotherapy led to an improvement in median progression-free survival compared with placebo/chemotherapy in patients with locally advanced or metastatic urothelial carcinoma.

The addition of the CDK4/6 inhibitor abemaciclib (Verzenio) to fulvestrant (Faslodex) led to a median 9.4-month overall survival benefit compared with fulvestrant with placebo in patients with hormone receptor–positive, HER2-negative advanced breast cancer who progressed on prior endocrine therapy.

The combination of ribociclib and fulvestrant led to an approximate 28% reduction in the risk of death compared with placebo and fulvestrant in postmenopausal patients with hormone receptor–positive, HER2-negative advanced breast cancer.

Sacituzumab govitecan demonstrated clinical activity with an overall response rate of 29% in patients with heavily pretreated metastatic urothelial carcinoma.

The first-line combination of nivolumab and ipilimumab led to a clinically meaningful improvement in overall survival versus chemotherapy in patients with advanced non–small cell lung cancer, regardless of PD-L1 expression.

The next-generation androgen receptor apalutamide, in combination with androgen deprivation therapy, demonstrated a 25% reduction in the risk of death compared with placebo/ADT in patients with nonmetastatic castration-resistant prostate cancer in the phase III SPARTAN trial.

The National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology for Soft Tissue Sarcoma to include a category 1 recommendation for pexidartinib (Turalio) for the treatment of patients with tenosynovial giant cell tumor.

The FDA has approved 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.

Two clinical trials evaluating blinatumomab compared with chemotherapy in pediatric patients with acute lymphoblastic leukemia were stopped early due to treatment benefit with the bispecific T-cell engager.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of nivolumab at a flat dosing schedule of either 240 mg over 30 minutes every 2 weeks, or 480 mg infused over 60 minutes every 4 weeks, for the adjuvant treatment of patients with melanoma who have involvement of lymph nodes or metastatic disease who have undergone complete resection.

The FDA has expanded the approval of the noninvasive colorectal cancer (CRC) screening test Cologuard to include eligible at-risk individuals ≥45 years.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of gilteritinib as a single agent for the treatment of adult patients with relapsed/refractory acute myeloid leukemia who have FLT3 mutations.

The uptick of biosimilars has led to a surge of new data and regulatory decisions in recent years, with a focus on similarity between biosimilars and their reference products while reducing healthcare costs. This week, data on subcutaneous formulations of one biosimilar and long-term experience with another were provided, as well as an authorization of a trastuzumab (Herceptin) biosimilar in Canada.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion to recommend approval of the combination of avelumab and axitinib for the frontline treatment of adult patients with advanced renal cell carcinoma.