Recent Drug Approvals

CURE, Winter Supplement 2012, Volume 11, Issue 0

Recent drug approvals for metastatic cancers.

On Sept. 27, the Food and Drug Administration announced that it had approved Stivarga (regorafenib) for patients with metastatic colorectal cancer (mCRC) who have progressed after trying other therapies. The FDA had granted the drug a priority review in late June, which guarantees a drug will be reviewed within six months.

Stivarga works as a multikinase inhibitor, which means it targets several different pathways that can promote tumor growth, including the vascular endothelial growth factor (VEGF) receptor, which signals tumor blood vessel growth, and c-KIT, an oncogene that also helps cancer growth. Patients take the drug orally, once daily in four-week cycles (three weeks on, one week off, before starting the therapy again).

The approval is based on the phase 3 CORRECT trial, which randomly assigned 760 patients with mCRC who had prior treatment to receive either Stivarga or a placebo. All patients in the trial received best supportive care. Stivarga was shown to extend median overall survival to 6.4 months compared with the five months for those in the placebo arm. The drug also delayed tumor growth by two months compared with the 1.7 months for those on placebo.

Common side effects include fatigue, hand-foot syndrome and diarrhea. The drug also carries a warning that severe and fatal liver toxicity can sometimes occur.

Stivarga has already been made available to some patients through an extended access program. For additional information, visit stivarga-us.com or call 866-639-2827.

On Aug. 31, the 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 1 percent of patients taking Xtandi had seizures. For more details, visit xtandihcp.com or call 855-898-2634.

On Aug. 3, the FDA approved Zaltrap (zivaflibercept) for treating patients with mCRC 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).

The approval is based on 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. Those in the Zaltrap arm had a median overall survival of 13.5 months compared with 12 months in the placebo arm. Zaltrap also extended progressionfree survival to 6.9 months compared with the 4.7 months for FOLFIRI plus placebo.

Serious side effects include 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 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 is indicated in combination with Herceptin (trastuzumab) and docetaxel in patients who haven’t had a previous anti-HER2 therapy or chemotherapy for metastatic disease.

Side effects include neutropenia (a type of low white blood cell count), febrile neutropenia and diarrhea. For additional information, visit perjeta.com/patient or call 888-249-4918.