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

 

Avastin Receives New FDA Indication

On November 14, 2014, Avastin® (bevacizumab) solution for intravenous infusion was approved by the FDA in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. 

Click Here to Access Practice Information from Genentech.

Click Here to read the entire prescribing information.

FDA Approves a New Indication for XTANDI® (enzalutamide) capsules

Astellas Pharma US, Inc. is pleased to announce that the US Food and Drug Administration (FDA) has approved a new indication for XTANDI, an androgen receptor inhibitor. XTANDI is now indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Please click here for Full Prescribing Information.

 

Velcade Receives New FDA Approval

Millennium: The Takeda Oncology Company is pleased to announce that VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) is now approved for patients with previously untreated MCL. VR-CAP is the first and only FDA-approved regimen for the treatment of patients with previously untreated MCL. 

Click Here to read the announcement from Millennium. 

Click Here for full prescribing information.

 

FDA Approves a New Indication for XTANDI®

Astellas Pharma US, Inc. is pleased to announce that the US Food and Drug Administration (FDA) has approved a new indication for XTANDI, an androgen receptor inhibitor. XTANDI is now indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).1

For more information and to read the Safety Information go to www.xtandihcp.com   click here to view Full Prescribing Information.