Oncology Business Management | Specialty

FDA Grants BI-1482694 Breakthrough Designation for T790M-Positive NSCLC

December 22nd 2015

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.

FDA Approves Two New Indications for Pembrolizumab in Advanced Melanoma

December 18th 2015

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

FDA Delays Decision on Rociletinib in NSCLC

December 16th 2015

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.

Indication-Specific Pricing Still a Long Way Off

December 14th 2015

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.

FDA Approves Alectinib for ALK-Positive NSCLC

December 11th 2015

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.

Complications, Costs Higher With Mastectomy Versus Lumpectomy for Early Breast Cancer

December 10th 2015

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.

FDA Grants Priority Review to Palbociclib in Pretreated HR+/HER2- Breast Cancer

December 10th 2015

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.

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.