Oncology Business Management

The FDA has approved a non-alcohol formulation of docetaxel as a treatment for patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

The FDA has granted a breakthrough therapy designation to the third-generation EGFR TKI BI-1482694 as a potential treatment for patients with EGFR T790M-positive non–small cell lung cancer.

The FDA has expanded the approval for single-agent pembrolizumab to include the frontline treatment of patients with advanced melanoma regardless of BRAF status.

The FDA has extended the review period for rociletinib in patients with EGFR T790M-positive non–small cell lung cancer by 3 months, to allow ample time to review additional data.

Cancer drugs in the United States have increased 5- to 10-fold since 2000, but several analyses indicate that this increase in cost does not match improvements in health and overall survival.

The FDA has granted an accelerated approval to alectinib as a treatment for patients with metastatic ALK-positive non–small cell lung cancer following progression on crizotinib.

The risk of complications from mastectomy plus reconstruction was increased by two-fold compared with lumpectomy plus whole breast irradiation, after adjustment for other treatment differences.

The FDA has granted a priority review to a supplemental new drug application for palbociclib (Ibrance) for use in combination with fulvestrant in pretreated patients with HR-positive, HER2-negative metastatic breast cancer.

The FDA approved elotuzumab (Empliciti) for use in combination therapy in patients with multiple myeloma following the failure of 1 to 3 prior therapies.

The FDA has requested additional data for the use of single-agent nivolumab in previously untreated patients with BRAF V600 mutation-positive advanced melanoma.

The FDA has expanded the approval for single-agent nivolumab (Opdivo) to include the frontline treatment of patients with BRAF wild-type advanced melanoma.

The FDA has approved necitumumab in combination with gemcitabine and cisplatin for the first-line treatment of patients with locally advanced or metastatic squamous non–small cell lung cancer.

The FDA has approved nivolumab as a treatment for patients with metastatic renal cell carcinoma following prior treatment with an anti-angiogenic therapy.

The FDA has granted a full approval to the combination of dabrafenib and trametinib for patients with unresectable or metastatic BRAF-mutated melanoma.

Jason Luke, MD, Assistant Professor of Medicine, the University of Chicago Medicine Comprehensive Cancer Center, discusses how inflammation in the tumor microenvironment can serve as a biomarker in melanoma.

The FDA has approved the oral proteasome inhibitor ixazomib in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma following progression on at least one prior therapy.

An FDA panel voted against approval of the immunotherapy MCNA as a treatment for patients with high-risk non-muscle invasive bladder cancer following first-line bacillus Calmette-Guérin therapy.

The FDA has assigned a priority review designation to the PD-1 inhibitor nivolumab as a treatment for patients with advanced renal cell carcinoma following prior antiangiogenic therapy.

The FDA has granted an accelerated approval to the CD38-targeted monoclonal antibody daratumumab as a monotherapy for patients with multiple myeloma following at least 3 prior therapies.

The FDA has requested additional clinical trial data to support a new drug application for rociletinib as a potential therapy for pretreated patients with EGFR T790M mutation-positive NSCLC.

The FDA has granted an accelerated approval to osimertinib for patients with advanced EGFR T790M mutation positive non–small cell lung cancer following prior therapy on a prior EGFR TKI.

The FDA has approved the combination of vemurafenib and cobimetinib as a treatment for patients with metastatic or unresectable BRAF V600E/K mutation-positive melanoma.

OncLive is proud to announce that nominations are open for the 4th Annual Giants of Cancer Care awards. The Giants of Cancer Care program celebrates the achievements of leading physicians and researchers who have devoted their time, talent and resources to improving care for the many patients and their families affected by cancer.

The FDA has granted a breakthrough therapy designation to pexidartinib as a potential therapy for patients with tenosynovial giant cell tumor for which surgical removal is contraindicate.

The FDA has approved talimogene laherparepvec for the treatment of patients with advanced melanoma.

The FDA has approved trabectedin for the treatment of patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have previously received chemotherapy that included an anthracycline.

The FDA issued a complete response letter to Spectrum Pharmaceuticals, informing the company that its new drug application (NDA) for the use of Captisol-enabled melphalan in multiple myeloma will not be approved in its current form.

Pazopanib demonstrated significant clinical activity for patients with RAI-refractory differentiated thyroid cancer; however, a predictive biomarker for the therapy could not be uncovered.