FDA Approves Amgen's IMLYGIC™

On October 27, 2015, the U.S. Food and Drug Administration approved IMLYGICTM (talimogene laherparepvec).

INDICATION
is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.

Limitations of use: IMLYGIC™ has not been shown to improve overall survival or have an effect on visceral metastases.

Please click here for the IMLYGICTM Full Prescribing Information and Medication Guide.

Bristol-Myers Squibb New FDA Approval for Opdivo

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Click Here to read the press release from Bristol-Myers Squibb. 

New FDA Approval for YONDELIS®

On October 23, 2015, Jansses Biotech, Inc. announced that the U.S. FDA approved YONDELIS® (trabectedin) for the Treatment of Patients with Unresectable or Metastatic Liposarcoma or Leiomyosarcoma, Two Common Subtypes of Soft Tissue Sarcoma. 

Click Here for the press release from Janssen.

FDA Approval for Opdivo

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy prior to receiving Opdivo. 

 

Click Here for the press release.

KEYTRUDA Receives Second Approval

KEYTRUDA has received a second approval from the US Food and Drug Administration (FDA). The approved recommended dose of KEYTRUDA is 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity. Select patients for second-line or greater treatment of metastatic NSCLC with KEYTRUDA based on the presence of positive programmed death ligand 1 (PD-L1) expression. Resources: Prescribing Information Medication Guide, Press Release, Announcement Letter. 

If you have any questions, please contact Mike Nicolucci, Account Manager,  Reimbursement, Merck (C) 913 522-6508, (F) 215 616-5889, E-Mail: mike.nicolucci@merck.com directly. 

FDA Approves Opdivo + Yervoy Regimen

Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Click Here for detailed information from Bristol-Myers Squibb. 

aHUS Efficacy and Safety from 2-year Extension Phase II Studies

Please click on the link below to read the new article in Kidney International:

Licht 2015. Efficacy and Safety of Eculizumab in Atypical Hemolytic Uremic Syndrome From 2-year Extensions of Phase 2 Studies

Click Here for Information About Safety and Prescribing Information:
http://www.soliris.net/sites/default/files/assets/soliris_pi.pdf

Results from a Second Clinical Validation Study of Oncotype DX® DCIS

REDWOOD CITY, Calif., July 14, 2015 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that Breast Cancer Research and Treatment published results from a second large clinical validation study of Oncotype DX® in patients with stage 0 breast cancer, also known as DCIS (ductal carcinoma in situ). The population-based study, conducted by the Ontario DCIS Study Group, reconfirmed that the Oncotype DX DCIS Score is a strong predictor of local recurrence (p<0.001), which could be either invasive breast cancer or DCIS.

"Our study analyzed the impact of the DCIS Score as an independent predictor of local recurrence in a population cohort of individuals with pure DCIS treated by breast-conserving surgery with clear margins," said lead investigator Eileen Rakovitch, M.D., FRCP(C), M.Sc., Sunnybrook Research Institute, Institute for Clinical Evaluative Sciences, Toronto.

Based on a population-based cohort of 828 DCIS tumor samples collected between 1994 and 2003 in Canada, the primary analysis focused on 571 patients who were treated with breast-conserving surgery alone and had clear margins. The newly published results of the study identified that the majority of studied DCIS patients (62 percent) were low risk based on the tumor biology revealed by the Oncotype DX DCIS Score. The remaining cases had an intermediate-risk or high-risk score, and these patients experienced a higher risk of local recurrence. These findings are consistent with those of the original ECOG-ACRIN Cancer Research Group clinical validation study, which demonstrated that the DCIS Score quantified the 10-year risk of local recurrence beyond clinical factors such as tumor size and grade. 


"This new publication, combined with a recently published study showing that Oncotype DX changes treatment decisions in nearly 30 percent of DCIS patients, supports broader adoption of our test and provides further confidence to physicians and their patients as they include the test in treatment decision-making," said Frederick Baehner, M.D., vice president, Pathology, Genomic Health.