Natalizumab [Tysabri]: The Progressive Multifocal Leukoencephalopathy (PML) Saga Continues

September 22, 2009

September 22, 2009 – From a MedWatch Alert, we learn that the American Food and Drug Administration (FDA) continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Natalizumab [Tysabri].  Natalizumab [Tysabri] was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.  From July 2006, (when Natalizumab [Tysabri] marketing resumed) to September 8, 2009, 13 reported cases of Natalizumab [Tysabri]-related PML were confirmed worldwide in patients being treated for MS with Natalizumab [Tysabri] monotherapy. There have been no postmarketing reports of PML in patients treated with Natalizumab [Tysabri] for Crohn’s disease. Less than 2% of Natalizumab [Tysabri] use in the United Staates has been in patients with Crohn’s disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

The risk for developing PML appears to increase with the number of Natalizumab [Tysabri] infusions received. At this time, the FDA is not requiring changes regarding PML to the Natalizumab [Tysabri] prescribing information or to the Natalizumab [Tysabri] management plan, called the TOUCH Prescribing Program.

Healthcare Professionals can find more information here.

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FDA Clears a Test for Ovarian Cancer: Test can help identify potential malignancies, guide surgical decisions

September 14, 2009

September 11, 2009 – Please find here the text (in italics) of a press release by the FDA on the newly approved OVA1 diagnostic test. This test may well add to the options physicians have today in treating patients based on the  individual status of their diseases (i.e., within the framework of personalized medicine).

The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

“Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications,” said Jeffrey Shuren, M.D., J.D., acting director of the FDA’s Center for Devices and Radiological Health.

The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

Mycophenolic acid [Myfortic]: Risk for Pure Red Cell Aplasia (PRCA)

September 4, 2009

September 4, 2009 – We learn that today, Novartis Pharmaceuticals Corporation notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Mycophenolic acid [Myfortic]. The WARNINGS and ADVERSE REACTIONS sections of the Mycophenolic acid [Myfortic] Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Mycophenolic acid [Myfortic] therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

Please read here the Dear Healthcare Professional Letter sent out by Novartis  Pharmaceuticals Corporation.

Please take also note of a related MedWatch Alert concerning Mycophenolate Mofetil [CellCept] and its association with PRCA, published on August 14, 2009.

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