FDA Approval for Keytruda

WHITEHOUSE STATION, N.J., Sept. 04, 2014 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. 

Click Here to read the entire press release

Click Here to read the prescribing information

Click Here to read the announcement letter
 
Click Here for information on the Keytruda Access Program 

New FDA Approval for IMBRUVICA

SUNNYVALE, CA, July 28, 2014 -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that the U.S. Food and Drug Administration (FDA) has granted IMBRUVICA® (ibrutinib) regular (full) approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naïve and previously treated del 17p CLL patients. 

Click Here to read the press release from Pharmacyclics. 

Click Here for the prescribing information.

Important Update from Noridian on Claims for Xoifigo

On July 16, 2014 Noridian posted the following important notice regarding claims for Xoifigo:


Claims with a date of service of September 1, 2014 or after, Noridian will begin requiring submission of the invoice price for payment for Radium 223 (Xoifigo). This radiopharmaceutical should be billed with A9699 when billing from the Medicare Physician Fee Schedule on a CMS-1500 Claim Form or electronically.

Providers must enter the name and dose of the radiopharmaceutical along with the invoice price in Item 19 of the CMS-1500 Claim Form or the electronic equivalent. Claims without this information will be denied as unprocessable.

Click Here to access this notice on the Noridian Website.

ASCO Survey - Be Counted

Be Counted in 2014 ASCO National Oncology Census – No Login Information Required


Please be counted in this year’s ASCO National Oncology Census – the only annual survey of the entire oncology community that aims to capture and describe changes in cancer care over time. The data and insights we obtained from the 2013 census are chronicled in ASCO’s The State of Cancer Care in America: 2014 and are driving ASCO’s policy and advocacy efforts.   New This Year: The 2014 survey tool does not require user IDs or passwords so you can click here and be counted immediately.

Oncotype DX New Study Results

DCIS - Genomic Health Announces Positive Topline Results of Second Large, Independent Validation Study of Oncotype DX® in DCIS Breast Cancer

Complete Data to be Submitted for Presentation at the 2014 San Antonio Breast Cancer Symposium

REDWOOD CITY, Calif., June 11, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive preliminary results from a second large, independent clinical validation study of Oncotype DX® in patients with a pre-invasive form of breast cancer, also known as DCIS (ductal carcinoma in situ).

The study, conducted by the Ontario DCIS Study Group in Canada, met its primary endpoint by demonstrating that the Oncotype DX DCIS Score™ predicts the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.

New Premera G-CSF Policy

Premera has posted a new G-CSF policy on their Website. The policy which is effective August 30, 2014 describes the conditions under which Tbo-filgrastim (Granix®),  Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) may be considered medically necessary and covered.  

Please take the time to read the policy and policy guidelines on the Premera Website: https://www.premera.com/medicalpolicies/CMI_158401.htm

New FDA Approval for Cyramza

On April 21, 2014, the FDA approved Lilly’s Cyramza (ramucirumab) to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. 

Cyramza is an angiogenesis inhibitor that blocks the blood supply to tumors. It is intended for patients whose cancer cannot be surgically removed (unresectable) or has spread (metastatic) after being treated with a fluoropyrimidine- or platinum-containing therapy.

For more information and to access the FDA press release:
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394107.htm

Clinical and reimbursement information is available at:
www.cyramzahcp.com

 

New FDA Approval for Vectibix

On May 23, 2014 the Food and Drug Administration (FDA) approved a new indication for Vectibix® (panitumumab) as follows: 

Vectibix® is indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC) as determined by an FDA-approved test for this use:

  • As first-line therapy in combination with FOLFOX
  • As monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy

Vectibix® is not indicated for the treatment of patients with KRAS-mutant mCRC or for whom KRAS mutation status is unknown.  

Please click here to link to the Vectibix® Prescribing Information (PI), including Boxed WARNING.