New FDA Approval for Lilly's CYRAMZA

On December 12, 2014, the US Food and Drug Administration (FDA) approved a new indication for CYRAMZA® (ramucirumab). CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. This is the third FDA-approval for CYRAMZA.

CYRAMZA is also indicated as a single agent, or in combination with paclitaxel, for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

For more information, please visit www.CYRAMZAhcp.com

Please click here for full Prescribing Information including Boxed Warning for hemorrhage.

 

Important Coding, Purchasing and Reimbursement Changes for Xofigo

Bayer has released information on new coding, purchasing and reimbursement changes for their drug Xofigo effective January 1, 2015.

Please Click Here to read the detailed information from Bayer.  

 

Bristol-Myers Squibb Announces FDA Approval for Opdivo

On December 22, 2014 the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of advanced melanoma.

The indication is for patients with unresectable or metastatic melanoma and disease progression after treatment with ipilimumab (Yervoy) and, for patients whose tumors are BRAF V600 mutation positive, a BRAF inhibitor.

Click Here for the Bristol-Myers Squibb Press Release. 

Click Here for a Fact Sheet on Opdivo.

Jakafi Receives New Indication

The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.

Click Here for the Jakafi PI

 

XGEVA Receives New FDA Approval

On December 5, 2014 the Food and Drug Administration (FDA) approved a new indication for XGEVA® (denosumab) as follows:

XGEVA® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Please click here to link to the updated XGEVA® Prescribing Information (PI).

Important Safety Information

XGEVA® is contraindicated in patients with pre-existing hypocalcemia and clinically significant hypersensitivity to XGEVA®.  XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported.  Osteonecrosis of the jaw and atypical fracture have been reported.  XGEVA® can cause fetal harm.  Females of reproductive potential should use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®.

 

News From Genomic Health

Positive Results of Largest Genomic Study in DCIS Reconfirm Oncotype DX is a Strong, Independent Predictor of Local Recurrence
Oral Presentation, Featured in the 2014 San Antonio Breast Cancer Symposium Press Program, to Occur on December 12 at 10:15 a.m. Central Time

SAN ANTONIO, Dec. 12, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from the second large clinical validation study of Oncotype DX® in patients with a pre-invasive form of breast cancer known as DCIS (ductal carcinoma in situ).  The study, conducted by the Ontario DCIS Study Group of Sunnybrook Health Sciences Centre in Canada, reconfirmed that the Oncotype DX DCIS Score is a strong predictor of local recurrence, which could be either invasive breast cancer or DCIS (p < 0.001). 

 

FDA Approves Liquid TREANDA®

The U.S. Food and Drug Administration (FDA) approved a liquid formulation of Teva Oncology’s TREANDA® (bendamustine HCI) Injection, for intravenous infusion. TREANDA is indicated for treatment of patients with: Chronic Lymphocytic Leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. Indolent B-cell non-Hodgkin Lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab containing regimen.

The LIQUID FORMULATION— TREANDA® (bendamustine HCl) Injection is available now. 

In addition to the Liquid formulation, TREANDA may still be available for a limited time as a single-use vial of lyophilized powder. 

Please click here for the Full TREANDA Liquid Formulation Prescribing Information.   

For more information about TREANDA, please visit: http://www.treanda.com.

 

Lilly's CYRAMZA Receives New FDA Indication

Eli Lilly and Company to announce that on November 5, 2014, the US Food and Drug Administration (FDA) approved a new indication for CYRAMZA® (ramucirumab). CYRAMZA as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. With this new indication, CYRAMZA can now be used for treatment as a single agent, or in combination with chemotherapy.

 

For more information, please visit www.CYRAMZAhcp.com.

 

Please click here for full Prescribing Information, including Boxed Warning for hemorrhage. 

 

Click here to read Lilly’s Press Release on CYRAMZA