The latest in cancer prevention, diagnosis and treatment.
On Jan. 28, the Food and Drug Administration approved Rituxan (rituximab) as a maintenance therapy for advanced follicular lymphoma, a type of non-Hodgkin lymphoma. Follicular lymphoma (FL) is typically incurable, with patients frequently relapsing and requiring additional treatments. Rituxan was initially approved in 1997. This recent approval is specifically for patients who responded to initial treatment with Rituxan plus chemotherapy to reduce the risk of relapse.
Initially presented at the annual meeting of the American Society of Clinical Oncology last summer, and with three-year follow-up data presented at the annual meeting of the American Society of Hematology in December, data showed that patients with advanced FL do better with ongoing Rituxan given every two months for two years. In the phase 3 trial (called PRIMA), researchers compared 24 months of Rituxan to the traditional four months in 1,018 patients with newly diagnosed disease. All patients received chemotherapy and induction therapy of four months of Rituxan, then were randomized to either an observation arm or continued Rituxan for an additional two years.
After a median follow-up of three years, researchers found that maintenance therapy increased progression-free survival from 60.3 percent to 78.6 percent. More patients also had complete remission, 55 percent of patients in the observation arm compared with 75 percent on maintenance therapy. Side effects were increased with the longer therapy, particularly infection and decreased white blood cell counts. For more information, visit www.rituxan.com or call 888-455-2220. —Elizabeth Whittington
Gardasil may be used and marketed as a vaccine to prevent anal cancer for people ages 9 to 26, according to an FDA ruling made Dec. 22. The decision to expand use of Gardasil was based on results from a trial showing significant protection against anal cancer and a precursor of anal cancer, called anal intraepithelial neoplasia (AIN).
Gardasil prevents infection by certain human papillomavirus (HPV) strains. The vaccine is already approved for prevention of cervical, vulvar and vaginal cancers, and some precancerous lesions in females; and for prevention of some types of genital warts in both males and females.
The recent clinical trial involved nearly 600 sexually active homosexual men ages 16 to 26—a population with the highest incidence of anal cancer. After two and a half years, those who received the vaccine were less likely to be infected with strains of HPV associated with anal cancer and AIN, and researchers calculated the vaccine was 77.5 percent effective against the two diseases.
Anal cancer affects men and women, the FDA noted in expanding the vaccine’s use by both genders. For more information, visit www.gardasil.com or call 908-423-1000. —Katy Human
On Dec. 17, the maker of blood cancer treatment Istodax (romidepsin) asked the FDA to expand the use of the drug to include patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy. PTCL is an often-aggressive immune system cancer affecting T-cells. The approval was based on results from a phase 2 trial presented during the American Society of Hematology meeting in December. The trial involved 130 patients with relapsed or refractory PTCL who had already received treatment, sometimes followed by stem cell transplant. There is no standard of care for such patients. Seventeen patients had a complete response to the drug, presenting no evidence of disease; 17 others had a partial response. Twenty-two patients withdrew from the trial due to severe side effects, which included pneumonia, fever, sepsis and vomiting.
Istodax is already approved for cutaneous T-cell lymphoma, which affects the skin, causing severe itchy rashes and often tumors. The drug is one of a relatively new class of cancer drugs called histone-deacetylase (HDAC) inhibitors, which affect how genes are expressed.
For more information, visit www.istodax.com or call 888-423-5436. —Katy Human
A pair of oral drugs used to treat advanced kidney cancer have proven effective against a rare type of pancreatic tumor, according to results of two phase 3 trials published in The New England Journal of Medicine. Sutent (sunitinib) and Afinitor (everolimus), both tumor-inhibiting drugs, more than doubled the progression-free survival time for patients with pancreatic neuroendocrine tumors, sometimes called islet cell tumors. This type of pancreatic cancer represents only about 1 percent of all pancreatic cancers and usually responds to treatment better than the more common form, according to the American Cancer Society. Sutent is also approved for gastrointestinal stromal tumors. —Jon Garinn
Two drugs designed to block cancer cells from repairing DNA damage (PARP inhibitors) recently met barriers to approval. Iniparib (BSI-201) failed to meet its goal to prolong survival or slow disease progression in metastatic triple-negative breast cancer patients.
In the phase 3 study, 519 women were randomized to receive standard chemotherapy with or without iniparib. Only in the subset of women who had received up to two prior chemotherapy treatments experienced improvement in survival, and representatives for Sanofi-Aventis have stated that there might be a benefit for second- or third-line treatment, confirming an earlier, smaller randomized trial in this setting that showed a survival advantage. The drug is undergoing review through the FDA’s fast-track approval process.
Another PARP inhibitor setback occurred when AstraZeneca opted to discontinue developing olaparib for breast cancer, instead choosing to focus on ovarian cancer. —Lindsay Ray
It’s one of the most difficult symptoms to treat in cancer patients—sudden, intense episodes of “breakthrough pain” that can hit without warning even when a patient is on medication for chronic pain. In January, the FDA approved a new weapon against breakthrough pain related to cancer: Abstral, a new powerful formulation of the narcotic fentanyl.
The agency approved Abstral for patients already using opioid medication of some sort around the clock. Approval followed the publication of several recent studies of pain management in opioid-tolerant patients experiencing breakthrough pain, with a variety of positive results, including improvement in pain relief, pain intensity difference and self-reported satisfaction with pain.
Side effects include nausea, constipation and drowsiness.
For more information, visit www.abstral.com or call 888-227-8725. —Katy Human
The FDA issued a safety warning in December that Anzemet injections (dolasetron) should no longer be used to prevent nausea and vomiting associated with chemotherapy. The drug can affect a patient’s heart rhythm, leading to a sometimes fatal condition. The agency had previously warned of the drug’s cardiovascular effects, but new evidence suggests a stronger association between the drug and heart rhythm changes. A tablet form of the pill may still be used to prevent nausea and vomiting associated with chemotherapy, and the lower dose of injected Anzemet used to treat postoperative nausea and vomiting. For more information, visit www.fda.gov/Drugs/DrugSafety/ucm237081.htm or call (800) 981-2491 (sanofi-aventis US, maker of Anzemet). —Katy Human