New FDA Approval for Xalkori

On November 20, 2013 the FDA granted regular approval for crizotinib (Xalkori, Pfizer, Inc.) capsules for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376058.html

New FDA Approval for NEXAVAR

On November 22, 2013, the FDA approved sorafenib (NEXAVAR tablets, Bayer Healthcare Pharmaceuticals Inc.) for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. Sorafenib was previously approved for treatment of renal cell carcinoma (2005) and hepatocellular carcinoma (2007). More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376547.htm

FDA Approves New Treatment for Chronic Lymphocytic Leukemia (CLL)

Genentech's GAZYVA (obinutuzumab) is a new FDA-approved anti-CD20 monoclonal antibody indicated, in combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).

GAZYVA was studied in a three arm, open label, randomized, multicenter, phase III trial.1 Please see the attached announcement for further details on why GAZYVA is an important new treatment option for patients with CLL, as well as GAZYVA full Prescribing Information for additional Important Safety Information, including Boxed Warnings.
 
The FDA designated GAZYVA a “Breakthrough Therapy” in May 2013. This designation is granted to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible.

•       Access the FDA approval press release
•       Click here for Full Prescribing Information


News From Genomic Health

Genomic Health Announces Oncotype DX - Colon Cancer Publication in Journal of Clinical Oncology Journal of Clinical Oncology Publishes Positive Results from Third Successful Validation in Stage II Colon Cancer, First Validation in Patients with Stage III Disease REDWOOD CITY, Calif., Nov. 13, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced that the Journal of Clinical Oncology (JCO) has published positive results from a large, independent validation study of the Oncotype DX® colon cancer test in patients from the National Surgical Adjuvant Breast and Bowel Project (NSABP) C-07 clinical trial. The results provide further confirmation that the Oncotype DX Recurrence Score® (RS) results predict recurrence risk and provide additional information beyond conventional risk factors, enabling better discrimination of absolute benefit of chemotherapy as a function of risk. Patients with a high Recurrence Score result can be expected to derive larger absolute chemotherapy treatment benefit than patients with a low Recurrence Score result in both stage II and stage III colon cancer. "The Recurrence Score result has shown us that there is a continuous biology in colon cancer versus a high or low ranking," said principal investigator Michael O'Connell, M.D., associate chairman of the NSABP. "This critical understanding of where a patient falls on that continuum is going to help both stage II and stage III colon cancer patients and their physicians make more informed decisions regarding adjuvant therapy." This large, independent validation study involved 892 patients and demonstrated that the Oncotype DX colon cancer Recurrence Score results predict risk of recurrence, disease-free survival and overall survival in stage II and stage III colon cancer patients receiving adjuvant chemotherapy (all p < 0.001). This is the third successful prospectively-designed study of the Oncotype DX colon cancer test in patients with stage II disease and the first validation study in patients with stage III disease, and it represents the ninth peer-reviewed publication reinforcing the value of the Oncotype DX colon cancer test for physicians, colon cancer patients and our healthcare system. The results add to the growing body of clinical evidence, in a suite of studies, with more than 5,000 patients supporting its clinical validity and impact on chemotherapy treatment decisions.

FDA Approval of Imbruvica (ibrutinib) for the treatment of patients with mantle cell lymphoma

HORSHAM, PA, NOVEMBER 13, 2013 – Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm374857.htm

New FDA Approval for REVLIMID

FDA approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

More Information: fda.gov

Governor Signs Standardized Prior Authorization Legislation

WSMOS was front and center in the lobbying for passage of SB 5267 in both the House and Senate.

On May 10, 2013 Governor Jay Inslee signed Senate Bill 5267.

SB 5267 provides for a committee, chaired by Senator Randi Becker and Representative Eileen Cody, to be selected to define the components of 4 standardized forms to be used for prior authorization of medications including chemotherapy as well as medical procedures and tests.

Insurers will be limited to the use of these forms.

The legislation further mandates that definite timelines be drawn for responses to authorization requests including “urgent” requests and when lack of a timely response constitutes authorization.

If this committee does not make final recommendations by November 15, 2013, then the Office of the Insurance Commissioner will be authorized to take over that responsibility.

The legislation mandates that the authorization standardization be implemented by January 1, 2015.
WSMOS highlighted the impact of the current status quo where practices are faced with a wide variety of prior authorization forms demanded by individual insurers and even within insurers with multiple insurance plans. This situation raises practice costs and creates unnecessary stress on employees and most importantly for patients awaiting scans and treatment.

WSMOS will continue to advocate for our patients and our practitioners to push this process to full implementation.

Jonathan Britell
WSMOS

Genomic Health Announces Medicare Expanded Coverage Policy for Oncotype DX® Breast

Click Here for more information.