Jason Harris

The FDA announced that it has approved the IMPACT tumor profiling assay, while also making it easier for some device manufacturers to bring their products to market.

The FDA has approved fulvestrant (Faslodex) for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio) to treat patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin (Adcetris) in adults with CD30-positive cutaneous T-cell lymphoma after at least 1 prior systemic therapy.

Bayer and Loxo Oncology have entered into a partnership to develop and market larotrectinib (LOXO-101) and LOXO-195 in the United States and worldwide.

Results from a systemic review and meta-analysis of data collected from nearly 45,000 women treated for cervical precancer found that high-risk HPV posttreatment was a more accurate predictor of treatment failure than incomplete rescission.

Pembrolizumab (Keytruda) induced an overall response rate of 30% in patients with heavily pretreated, PD-L1–positive advanced esophageal carcinoma.

Topline results from the MONALESSA-7 trial showed that ribociclib met its primary endpoint for progression-free survival in premenopausal women with hormone-receptor

The FDA today lifted clinical holds placed on 2 phase I trials investigating a gene-edited allogeneic CAR T-cell therapy known as UCART123.

Nivolumab reduced the risk of death by 26% compared with everolimus in patients with previously treated advanced renal cell carcinoma.

The European Medicines Agency (EMA) has received a Marketing Authorization Application (MAA) for tisagenlecleucel (Kymriah) for 2 forms of advanced lymphoma.

Researchers are seeking to determine whether the plethora of new therapies that have been introduced in recent years in the advanced and metastatic settings can benefit patients at risk of recurrence earlier in the treatment timeline for melanoma.

In phase Ib results from the KEYNOTE-028 trial, pembrolizumab (Keytruda) was found to be active in cervical cancer while demonstrating safety results similar to previous studies with the PD-1 inhibitor.

According to phase III results from the FOLL05 trial, the combination of rituximab plus cyclophosphamide, vincristine, and prednisone produced survival results comparable with standard-of-care regimens in patients with advanced symptomatic follicular lymphoma.

Pexidartinib met its primary endpoint of tumor response as measured by tumor size reduction in patients with symptomatic tenosynovial giant cell tumor where surgical resection is contraindicated.

The FDA has granted GSK2857916 a breakthrough therapy designation for patients with relapsed/refractory multiple myeloma.

Patients with peripheral T-cell lymphoma are more likely to have superior overall survival if they have previously demonstrated event-free survival at 24 months.

More than half of elderly, treatment-naïve patients with AML assigned to treatment with guadecitabine had a composite complete response irrespective of dosage or schedule.

The UK’s National Institute for Health and Care Excellence is recommending the use of atezolizumab for treatment-naïve patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-based therapy.

Novartis has filed a supplemental biologics license application with the FDA to expand the indication for tisagenlecleucel (Kymriah) to include adults with relapsed/refractory DLBCL who are ineligible for ASCT.

Merck has announced that it has withdrawn its European application for pembrolizumab in combination with pemetrexed and carboplatin as a first-line treatment for metastatic nonsquamous non-small cell lung cancer.

Novartis has announced a planned $3.9-billion acquisition of Advanced Accelerator Applications, a radiopharmaceutical company that develops, produces, and commercializes Molecular Nuclear Medicines.

Glembatumumab vedotin (CDX-011) induced a disease control rate of 61% in patients with metastatic uveal melanoma, despite a low a low objective response rate of 6%.

The FDA has accepted a supplemental biologics license application for bevacizumab (Avastin) for the first-line treatment of advanced ovarian cancer.

Ten-year results from the TEAM trial on exemestane alone and sequential treatment with tamoxifen followed by exemestane for postmenopausal women with hormone receptor-positive breast cancer showed they were reasonable treatment options.

Treatment with prolonged native E. coli asparaginase therapy for children with acute lymphoblastic leukemia or non-Hodgkin lymphoma not only failed to improve survival versus the standard regimen, but also resulted in an increase in infections and allergy.

The combination of clofarabine, cyclophosphamide, and etoposide reached an overall response rate of 41% in a small study of children and adolescents with relapsed/refractory acute myeloid leukemia.

Higher-dose, once-weekly carfilzomib (Kyprolis) demonstrated superior efficacy for patients with relapsed/refractory multiple myeloma compared with a lower-dose, twice-weekly regimen.

The presence of metastatic lymph nodes was directly correlated with poorer survival in patients with oral cancer, according to findings published in the Journal of Clinical Oncology.

Investigators sought to assess the efficacy of adjuvant surgery after concurrent chemoradiotherapy in patients with bulky squamous cell carcinoma of the uterine cervix

The FDA has awarded the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) a breakthrough therapy designation for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection.