U.S. FDA Approves IMBRUVICA® (ibrutinib) for First-line Treatment of Chronic Lymphocytic Leukemia

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL).[i] The approval is based on data from the Phase 3 RESONATE-2 (PCYC-1115) study, the first head-to-head clinical trial comparing IMBRUVICA to a chemotherapy agent. Results showed IMBRUVICA significantly extended progression-free survival (PFS; the primary endpoint) and increased overall response rate (ORR; a key secondary endpoint) compared to chlorambucil in previously untreated patients with CLL age 65 or older. IMBRUVICA is now approved for use in all lines of CLL therapy, considerably expanding the number of patients who may benefit from this treatment. This broadens the indication beyond the initial CLL approval in February 2014 for the treatment of patients with CLL who have received at least one prior therapy and in July 2014 for CLL patients with del 17p,1 a genetic mutation typically associated with poor treatment outcomes.[ii] IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.


[i] IMBRUVICA Prescribing Information, March 2016.

2 NCCN Clinical Practice Guidelines in Oncology. Non-Hodgkin’s Lymphomas. Version 2.2016. Available from: http://www.nccn.org/professionals/physician_gls/pdf/nhl.pdf. Accessed March 2016.

Click Here to read the entire Press Release from Janssen. 

New FDA Approval for Merck'ssingle-dose EMEND® (fosaprepitant dimeglumine)

On Feb. 4, 2016 Merck announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). 

Click Here to read the Press Release from Merck.

Click Here to read Merck's Announcement Letter. 

FDA Expands Use of Bristol-Myers Squibb's Opdivo + Yervoy Regimen

Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval.

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

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.