FDA Expands Use of Bristol-Myers Squibb's Opdivo

On January 23, 2016 Bristol-Myers Squibb Company announced that the FDA has approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. 

In the press release, Bristol-Myers Squibb states, "This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which PFS and overall survival (OS) were co-primary endpoints."

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

Genomic Health News

Genomic Health reports the initial results from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, a multi-center prospectively conducted trial of more than 10,000 women with early stage breast cancer sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) with support from Genomic Health, Inc.

The study demonstrated that a group of trial participants with low 21-gene recurrence score (Oncotype DX® Recurrence Score®) results of 10 or less who received hormonal therapy alone without chemotherapy had less than a one percent chance of distant recurrence at five years.

Click Here to read the press release from Genomic Health

Genomic Health Article on Study Results

On December 15, 2015 Genomic Health, Inc. announced results from multiple Oncotype DX® breast cancer test studies at the 38th CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) reconfirming that Oncotype DX accurately predicts clinical outcomes - including risk of recurrence and breast cancer survival - in early-stage patients with invasive breast cancer. Data include results from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI); complete results from a multi-center study from Clalit Health Services, the largest Health Maintenance Organization in Israel; and additional analysis from theTrial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by the ECOG-ACRIN Cancer Research Group.

FDA Approves Expanded Indication for Merck’s KEYTRUDA®

On Dec. 18, 2015 Merck announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. 

Please click on the links below to read the Press Release and FDA Approval Letter:

Press Release

FDA Approval Letter

New J Code for CYRAMZA®

The Centers for Medicare & Medicaid Services has announced the assignment of a product-specific code for CYRAMZA® ramucirumab), . The new code, J9308, is defined as injection, ramucirumab, 5 mg and is effective January 1, 2016.

J Code for KEYTRUDA®

KEYTRUDA has been assigned a permanent HCPCS* code, effective January 1, 2016:

HCPCS Code J9271: Injection, pembrolizumab, 1 mg

Click Here to read the Coding Update from Merck

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 www.Portrazza.com/hcp 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 NINLARO-hcp.com/1Point

Click here for highlights of the Prescribing Information