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. 

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:

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. 

Sandoz launches ZarxioTM (filgrastim-sndz)

On September 3, Sandoz, a Novartis company, announced that Zarxio™ (filgrastim-sndz) is now available in the United States. Zarxio is the first biosimilar approved by the US Food and Drug Administration (FDA) and the first to launch in the US.

Click Here to read the full press release.

Proposed Method of Reimbursement for Biosimilars

The Biosimilars Forum issued comments in response to the 2016 proposed rules released by the Center for Medicare and Medicaid Services (CMS) regarding biosimilar payment. As currently written, the Part B rule proposes that multiple biosimilars to the same reference product be grouped and issued the same J-code for Medicare reimbursement purposes.

The following is a summary of the Biosimilars Forum’s general comments to the proposed Part B rule. 

Biosimilars Forum’s General Comments to the Proposed Rule 

We strongly disagree with CMS’s intent to group all biosimilar products of a single reference product under the same HCPCS code. We urge CMS to enact a final payment rule that assigns each biosimilar product of a reference biologic its own payment amount and a unique HCPCS code. CMS’s proposed approach contradicts the statutory language of the Section 1847A of the Social Security Act. In addition, CMS’s interpretation inappropriately treats biosimilar products as if they were multisource or generic drugs. This treatment is inconsistent with not only how the Food and Drug Administration (“FDA”) classifies biosimilars, but also how CMS itself defines biosimilar products under Medicaid and Medicare Part D. Finally, CMS’s proposed payment methodology is likely to dramatically reduce investment in, and the subsequent availability of, biosimilar products, which is clearly against the intent of Congress in providing for a vibrant U.S. biosimilars market."

To read the Forum’s complete comments, click here: (Part B Submission (PDF File) and HOPPS NPRM Submission (PDF File)).

FDA Issues Label Change for ADCETRIS®

On Aug 17, 2015, the FDA issued a label change for ADCETRIS® (brentuximab vedotin). 

 Key label changes include:

FDA approval for the treatment of patients with Classical Hodgkin Lymphoma Patients at High Risk of Relapse or Progression as Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation. This approval was based upon data from the placebo-controlled randomized AETHERA trial.

Click Here for the updated USPI.

FDA Approves New Indication for Kyprolis

Onyx Pharmaceuticals Inc., an Amgen subsidiary, announced that on July 24, 2015, the U.S. Food and Drug Administration approved a new indication for Kyprolis® (carfilzomib) for injection. KYPROLIS can now be used in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy.

Trade Name - KYPROLIS


Strength - 60MG


NDC* - 76075-0101-01


Pack Size - 60mg X 1 Vial

Dosage Form - Injection, Powder, Lyophilized, for Solution

*Note that the product's NDC code has been "zero-filled" to ensure creation of an 11-digit code that meets CMS standards. The zero-fill location is indicated in bold.2

If you require any additional information or have specific questions regarding this correspondence, please contact the Onyx Pharmaceuticals 360™ Program at 855-ONYX-360 (855-669-9360).


 Click Here to read the Prescribing Information.