The latest in cancer prevention, diagnosis & treatment.
On Feb. 22, Kadcyla (ado-trastuzumab emtansine or T-DM1) was approved by the Food and Drug Administration (FDA) to treat patients with metastatic, HER2-positive breast cancer. An antibody-drug conjugate, Kadcyla fuses the chemotherapy drug emtansine to the antibody Herceptin (trastuzumab) to target HER2 receptors on cancer cells. The approval was based on results from the phase 3 EMILIA trial, which enrolled 991 patients who had previously been treated with Herceptin and a taxane-based chemotherapy. Patients were randomly assigned to either receive Kadcyla or the current standard—a combination of Xeloda (capecitabine) and Tykerb (lapatinib). Those in the Kadcyla arm had a median overall survival of 30.9 months compared with 25.1 months for those in the combination arm.
Side effects included low platelet count, vomiting, diarrhea and hand-foot syndrome. For details, visit kadcyla.com or call 877-436-3683.
The FDA approved Pomalyst (pomalidomide) on Feb. 8 to treat patients with multiple myeloma whose disease has progressed during or within 60 days after treatment with at least two therapies, such as Revlimid (lenalidomide) or Velcade (bortezomib).
The approval was based on a phase 2 clinical trial, in which patients received either Pomalyst and low-dose dexemethasone, a type of steroid, or Pomalyst alone. In those on Pomalyst alone, 7.4 percent had their cancer completely or partially disappear, compared with 29.2 percent for those receiving the combination. This response lasted for more than seven months in the combination arm.
Side effects included low white and red blood cell counts, fever and infections. For details, visit pomalyst.com or call 800-931-8691.
On Dec. 14, the FDA approved Iclusig (ponatinib) to treat adults with tyrosine kinase inhibitor (TKI)-resistant or intolerant Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and chronic myeloid leukemia in the chronic, accelerated and blast phases. Both diseases contain the mutant BCR-ABL gene, which produces the bcr-abl tyrosine kinase, a protein that signals malignant white blood cells to grow. TKIs typically deactivate these proteins, but for some patients with the mutant gene T315I, TKIs are prevented from reaching these proteins. Iclusig targets cells with the T315I mutation and thwarts other mutations that make these cells resistant to treatment with traditional TKIs.
Side effects included high blood pressure, abdominal and joint pain, rash and fatigue. Iclusig also carries a boxed warning that it can cause blood clots and liver toxicity.
For details, visit iclusig.com or call 855-552-7423.
On Nov. 29, Cometriq (cabozantinib) received FDA approval for treating patients with metastatic medullary thyroid cancer. Although an estimated 56,000 Americans received a thyroid cancer diagnosis in 2012, only about 2,240 of these cases were medullary.
The approval was based on a 330-patient trial in which those who received Cometriq lived an average of 7.2 months longer without their cancer growing than patients who received placebo. Also, 27 percent of patients on the drug saw their tumors shrink, whereas for those on the placebo, there were no tumor size reductions.
Side effects included diarrhea, mouth sores, nausea and fatigue. A boxed warning also advises that severe bleeding and holes in the colon occurred in some patients taking this drug.
For details, visit cometriq.com or call 855- 253-3273.
In 2011, the FDA approved Zytiga (abiraterone acetate) to treat men with metastatic, hormone-resistant prostate cancer after their cancer had progressed while on docetaxel. But on Dec. 10, the FDA expanded Zytiga’s indication to treat this patient population before they’ve received chemotherapy.
The approval was based on a study of 1,088 men with metastatic, hormone-resistant prostate cancer who had not previously had chemotherapy. Men taking Zytiga had a median overall survival of 35.3 months compared with 30.1 months for those taking a placebo.
Side effects included fatigue, joint swelling, diarrhea and vomiting.
For details, visit zytiga.com or call 855-998-4421.