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Pipeline

The latest in cancer prevention, diagnosis & treatment.

BY Lindsay Ray
PUBLISHED June 13, 2012

The Food and Drug Administration (FDA) approved Votrient (pazopanib) for advanced soft tissue sarcoma on April 26. The drug is indicated for patients who have received at least one prior chemotherapy treatment, but not for those who have adipocytic soft tissue sarcoma and gastrointestinal stromal tumors (GIST). 

There are around 50 different typse of soft tissue sarcomas. They can occur anywhere in the body, but most develop in the arms or legs. 

The warning sections on several cancer drugs have been updated.

The warning label for Sutent (sunitinib) has new sections about osteonecrosis of the jaw (ONJ) and tumor lysis syndrome (TLS). TLS has been linked with Sutent use, primarily in renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST) patients. TLS is a condition in which tumor cells break apart as they die, releasing their contents into the bloodstream and potentially causing organ damage.

The warning for Zometa (zoledronic acid), a bisphosphonate, now indicates that atypical fractures in the femur can occur while on the medication. Injuries can result after little or no trauma, and, for weeks or months, patients can experience thigh or groin pain before exhibiting a complete fracture.

Patients with multiple myeloma are cautioned to weigh the benefits of Revlimid (lenalidomide) treatment against the risks of second primary cancers, particularly acute myelogenous leukemia and Hodgkin lymphoma.

Tarceva (erlotinib), which is used to treat non-small cell lung cancer and pancreatic cancer, has a stronger warning for patients also taking warfarin or other coumarin-derivative anticoagulants. The label has been updated to warn that, in some cases, those taking these drugs along with Tarceva have a higher risk of fatal bleeding events, so patients should be monitored regularly.

Afinitor (everolimus), which is currently approved for patients with advanced pancreatic neuroendocrine tumors (PNET), advanced RCC and subependymal giant-cell astrocytoma (SEGA) associated with tuberous sclerosis, has an updated warnings section. Patients with PNET and RCC who also have severe liver impairment can take a reduced dose if they decide the benefits outweigh the risks. However, Afinitor is not recommended for SEGA patients who have severe liver damage.

On March 27, the FDA approved the Avioq HTLV-I/II Microelisa System, which tests for antibodies to viruses associated with several diseases, including some forms of leukemia, such as adult T-cell leukemia/lymphoma and neurologic diseases.

The test detects antibodies for Human T-Lymphotropic Virus Types I and II (HTLV-I and HTLV-II) in blood donors, as well as aids in diagnosing a viral infection. Screening blood donations for the viruses, which are transmitted via transfusion, reused syringes and breastfeeding, is required in the U.S. to ensure safe transfusions.

The test is also approved for screening the serum and plasma of organ donors.

Last year, the FDA approved Dificid (fidaxomicin) for Clostridium difficile–associated diarrhea in adults, and recent research indicates that this drug is more effective than vancomycin in adult cancer patients.

An analysis in cancer patients was done on data from two phase 3 trials, with one arm receiving Dificid and the other receiving vancomycin. Patients receiving Dificid were five times more likely to have a clinical response and three times more likely to maintain that response. They were also less likely to have a recurrence of C. difficile–associated diarrhea.

Cancer patients in particular are vulnerable to C. difficile due to a weakened immune system from the disease or treatment. In March, the Centers for Disease Control and Prevention stated that C. difficile infection and the related diarrhea has been linked to 14,000 deaths in the U.S. and is often transmitted during a hospital stay.

The FDA has approved Perjeta (pertuzumab) for patients with HER2-positive breast cancer that is metastatic or has recurred locally and can't be surgically removed. Perjeta should be used in combination with Herceptin (trastuzumab) and docetaxel in patients who haven't had a previous therapy or have relapsed after adjuvant treatment.

Perjeta is a monoclonal antibody that works by preventing the HER2 receptor from pairing with other HER receptors and stymieing the proliferation of cancer cells. Perjeta and Herceptin are thought to complement one another as they both target HER2 but do so in different areas.

The approval comes on the heels of a priority review, which was granted on evidence out of the phase 3 CLEOPATRA trial. 808 previously untreated, metastatic HER2-positive breast cancer patients were randomized to receive either the Perjeta-based regimen or Herceptin plus docetaxel and placebo. Patients in the Perjeta arm had a median progression-free survival of 18.5 months compared with 12.4 months in the Herceptin-docetaxel arm. Side effects include neutropenia, febrile neutropenia and diarrhea.

Perjeta is also being studied in early-stage HER2-positive breast cancer and HER2-positive gastric cancer. For more information, visit Perjeta.com or call 888-249-4918.

Votrient works by inhibiting the growth of new blood vessels that feed tumors and help them to grow. It was approved based on a randomized, multicenter trial in which 369 patients were assigned to either receive Votrient or a placebo. Those in the Votrient arm had a median of 4.6 months progression-free survival compared with the 1.6 months for those on placebo.

Common side effects include diarrhea, nausea, decreased appetite and fatigue, among others. Votrient also carries a boxed warning for the potential risk of liver damage, which can sometimes be fatal. 

Votrient was also approved in 2009 for advanced renal cell carcinoma. For more information, call 888-825-5249.

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