New FDA Approval for Portrazza™

On November 24, 2015, the US Food and Drug Administration (FDA) approved Portrazza, an epidermal growth factor receptor (EGFR) antagonist, indicated in combination with gemcitabine and cisplatin for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). Portrazza is not indicated for the treatment of nonsquamous NSCLC.


Please visit for more information.


Please click here for full Prescribing Information, and important Safety Information for Portrazza.

Takeda Oncology Announces Comprehensive Support Program for NINLARO®

Takeda Oncology has just launched a new comprehensive support program for NINLARO® (ixazomib) patients and their healthcare providers. NINLARO 1Point offers an array of access and coverage services.


The NINLARO 1Point dedicated case management team can deliver personalized services that help patients and providers navigate coverage requirements for NINLARO, streamline product access, and connect to helpful resources. Services include:

·       Benefit verification and prior authorization assistance

·       Assistance with appealing a payer denial

·       NINLARO Co-Pay Assistance Program enrollment for eligible, commercially insured patients

·       Specialty pharmacy referral and coordination

·       Referral to alternative funding sources and third-party foundations

·       Connection to support services, including referrals for transportation services, legal support, and national and local organizations for counseling

·       Patient Assistance Program application


For more information on access, coverage, and available support and services, contact a NINLARO 1Point case manager at:

1-844-N1POINT (1-844-617-6468), Option 2, Monday-Friday, 8AM-8PM ET

Or visit NINLARO 1Point at

Click here for highlights of the Prescribing Information

FDA Approves Amgen's IMLYGIC™

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

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: 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.