Oncology Business Management | Specialty

FDA Approves Elotuzumab for Multiple Myeloma

November 30th 2015

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

FDA Issues Complete Response Letter for Nivolumab in BRAF-Mutant Melanoma

November 27th 2015

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

FDA Approves Frontline Nivolumab for Advanced Melanoma

November 24th 2015

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

FDA Approves First-Line Nivolumab for Advanced Melanoma

November 24th 2015

FDA Approves Necitumumab for Squamous NSCLC

November 24th 2015

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.

FDA Approves Nivolumab for Metastatic Renal Cell Carcinoma

November 23rd 2015

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

FDA Grants Dabrafenib/Trametinib Full Approval for BRAF-Mutant Melanoma

November 20th 2015

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

Dr. Jason Luke on Utilizing the Tumor Microenvironment as a Biomarker for Immunotherapy Response

November 20th 2015

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.

FDA Approves Ixazomib for Relapsed Multiple Myeloma

November 20th 2015

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.

FDA Panel Rejects Immunotherapy MCNA in Bladder Cancer

November 18th 2015

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.

FDA Grants Priority Review to Nivolumab for Renal Cell Carcinoma

November 16th 2015

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.

FDA Approves Daratumumab for Pretreated Multiple Myeloma

November 16th 2015

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.

FDA Requests Additional Data for Rociletinib in EGFR T790M-Mutant NSCLC

November 16th 2015

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.

FDA Approves Osimertinib for EGFR T790M-Positive NSCLC

November 13th 2015

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.

FDA Approves Vemurafenib/Cobimetinib Combo for Melanoma

November 10th 2015

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.

Call for Nominations for the 4th Annual Giants of Cancer Care Awards

November 4th 2015

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.

FDA Grants Pexidartinib Breakthrough Status for Tenosynovial Giant Cell Tumor

November 2nd 2015

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.

FDA Approves MM-398, T-VEC, and Trabectedin, Cabozantinib RCC FDA Submission Started, New Pembrolizumab Data, and More

October 31st 2015

FDA Approves T-VEC for Advanced Melanoma

October 27th 2015

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

FDA Approves Trabectedin in Soft Tissue Sarcomas

October 23rd 2015

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.