The latest in cancer prevention, diagnosis & treatment.
On Aug. 31, the Food and Drug Administration (FDA) approved Xtandi (enzalutamide, formerly known as MDV3100) for patients with metastatic castration-resistant prostate cancer that has spread or recurred after surgery or hormone therapy. Patients also must have been previously treated with docetaxel. The approval comes three months ahead of schedule after the FDA granted the drug a priority review, which guarantees a six-month evaluation for promising treatments.
A targeted therapy, Xtandi works by preventing testosterone, a hormone that drives prostate cancer cells’ growth, from binding to the cell’s androgen receptor as well as helping to induce self-destruction of the tumor cell.
The drug’s effectiveness was proven in the AFFIRM trial which randomized 1,199 patients with the experimental treatment versus placebo. Xtandi was shown to improve median overall survival by 4.8 months compared with a placebo. Results presented at this year’s American Society of Clinical Oncology Genitourinary Cancer Symposium showed the drug also promoted tumor shrinkage, caused a significant decline in PSA levels and delayed cancer growth by five months.
Common side effects include fatigue, diarrhea, musculoskeletal pain, hot flashes and headaches, among others. About one percent of patients taking Xtandi had seizures. For more details, visit medivation.com.
On Aug. 3, the FDA approved Zaltrap (ziv-aflibercept) for treating patients with metastatic colorectal cancer and tumors that have progressed or are resistant to oxaliplatin-containing therapies. The drug is used in combination with the standard colorectal cancer chemo regimen FOLFIRI (leucovorin, 5-FU [fluorouracil] and irinotecan).
Zaltrap is an angiogenesis inhibitor, meaning it cuts off the tumor’s blood supply, thereby inhibiting growth. Essentially, Zaltrap targets the vascular endothelial growth factor (VEGF), like Avastin (bevacizumab), but does so by setting a trap and acting like the VEGF receptor, preventing two proteins from starting new blood vessel growth.
The approval is based on results from the phase 3 VELOUR trial in which 1,226 patients who had previously received an oxaliplatin treatment combination were randomized to receive FOLFIRI plus either Zaltrap or a placebo. The patients in the Zaltrap arm had a median overall survival of 13.5 months compared with 12 months in the placebo arm. Zaltrap also extended progression-free survival to 6.9 months compared with the 4.7 months for FOLFIRI plus placebo.
Zaltrap includes a boxed warning for serious side effects, including severe bleeding, particularly gastrointestinal bleeding, and holes (perforations) in the gastrointestinal tract. It also might take longer for wounds to heal.
Other side effects include diarrhea, fatigue, neutropenia, mouth ulcers and decreased appetite.
For additional information, visit zaltrap.com or call 855-925-8727.
On July 20, the FDA approved Afinitor (everolimus) in combination with exemestane to treat postmenopausal women with advanced estrogen-receptor positive breast cancer after treatment with either of the aromatase inhibitors letrozole or anastrozole.
Afinitor inhibits the mTOR pathway, which can lead to resistance to hormone therapy.
The approval was based on a phase 3 study of 724 patients with metastatic hormone-positive breast cancer who were randomized to receive either Afinitor and exemestane or exemestane alone. Patients in the combination arm had a 4.6-month increase in median progression-free survival compared with those on exemestane alone.
Side effects include mouth ulcers, fatigue, diarrhea and high blood sugar.
For additional information, visit afinitor.com or call 800-282-7630.
On June 11, the FDA 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 anti-HER2 therapy or chemotherapy for metastatic disease.
Perjeta prevents the HER2 receptor from pairing with other human epidermal growth factor receptors (HER) and stops 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.
Side effects include neutropenia, febrile neutropenia and diarrhea.
For details, visit perjeta.com/patient or call 888-249-4918.