The latest in cancer prevention, diagnosis & treatment.
On Nov. 20, the Food and Drug Administration (FDA) granted regular approval to Xalkori (crizotinib) to treat patients with advanced non-small cell lung cancer (NSCLC) whose tumors also have the abnormal anaplastic lymphoma kinase (ALK) gene, as detected by the FDAapproved companion diagnostic test.
Xalkori previously received accelerated approval in August 2011, but the need for follow-up trials to confirm its benefit was indicated.
A randomized trial with 347 participants with ALK-positive NSCLC was conducted in which participants received Xalkori or chemotherapy. Those who received Xalkori had improved progression-free survival over those who received chemotherapy (7.7 and 3 months, respectively).
The overall response rate (percentage of participants who experienced partial or complete tumor shrinkage) was also better for those taking Xalkori: 65 percent versus 20 percent. Participants taking Xalkori also experienced a longer response, but there was no difference in overall survival.
Common side effects included nausea, vomiting, fatigue, diarrhea and visual disorders. Serious side effects, such as pneumonia or clotting in the lung, were also experienced by some participants.
For more information, visit xalkori.com or call 877-744-5675.
The FDA approved Imbruvica (ibrutinib) on Nov. 13 to treat patients with mantle cell lymphoma (MCL), a rare type of non- Hodgkin lymphoma, who had received at least one prior therapy. Imbruvica was the second drug with a breakthrough therapy designation to receive FDA approval (see “Special Report” for details about this new approval process).
MCL, which accounts for about 6 percent of non-Hodgkin lymphoma cases, is usually at an advanced stage when diagnosed and can be difficult to treat even though it is slow-growing. Imbruvica is a tyrosine kinase inhibitor that works by stopping a key enzyme (Bruton’s tyrosine kinase) that helps the cancerous cells survive and thrive.
Imbruvica is the third drug approved to treat this cancer; Velcade (bortezomib) and Revlimid (lenalidomide) were previously approved to treat this disease.
The approval is based on a study in which 111 participants with MCL received Imbruvica daily until their cancer progressed or they could no longer tolerate the side effects. Almost 66 percent had their cancer shrink or disappear (overall response rate). The median duration of response was 17.5 months.
There are no data about improved survival or improved disease-related symptoms.
Common side effects included decreased levels of blood platelets and red and white blood cells, nausea, vomiting, fatigue and musculoskeletal pain.
For more information, visit imbruvica.com or call 877-877-3536.
On Nov. 1, the FDA approved Gazyva (obinutuzumab), in combination with chlorambucil, for patients with previously untreated chronic lymphocytic leukemia (CLL). Gazyva was the first FDA-approved drug with a breakthrough therapy designation.
CLL starts as a buildup of abnormal white blood cells in the bone marrow that then spread into the blood. Gazyva is a monoclonal antibody that stimulates the immune system to attack the cancer cells.
Approval was based on a trial in which 356 participants with previously untreated CLL received either Gazyva with chlorambucil or chlorambucil alone. Participants receiving the combination experienced improved progression-free survival (23 months) over those who received chlorambucil alone (11.1 months).
Common side effects included musculoskeletal pain, fever, and low blood cell and platelet counts.
For more information, visit gazyva.com or call 888-249-4918.
The FDA approved Perjeta (pertuzumab) on Sept. 30 to treat patients with early-stage breast cancer prior to surgery (neoadjuvant). Last year, Perjeta received approval to treat patients with metastatic HER2-positive breast cancer.
Perjeta is the first drug approved for the neoadjuvant treatment of breast cancer. It is still intended for patients who are HER2-positive, but has now been extended to include those with inflammatory, locally advanced or early-stage breast cancer who are at high risk. Perjeta is used in combination with Herceptin (trastuzumab), a monoclonal antibody that blocks HER2, and chemotherapy. Depending on the combination used, chemotherapy can be used after surgery, as well. Herceptin, however, should be continued after surgery to complete a year of treatment.
The drug’s approval was based on a phase 2 trial involving 417 participants who were randomly assigned to receive one of four treatment combinations prior to surgery: Herceptin and docetaxel; Perjeta, Herceptin and docetaxel; Perjeta and Herceptin; or Perjeta and docetaxel. Thirty-nine percent of those receiving the Perjeta- Herceptin-docetaxel combination achieved a complete pathologic response, meaning there was no detectable invasive cancer in the breast and lymph nodes. Only about 21 percent of those who received Herceptin plus docetaxel achieved a complete pathologic response.
Perjeta is the first cancer drug approved based on a complete pathologic response instead of traditional endpoints, such as survival data and progression-free survival.
Common side effects for participants receiving the Perjeta-Herceptin-docetaxel combination included hair loss, a decrease in white blood cells (neutropenia) and nausea. Other side effects included severe allergic reactions, hypersensitivity and decreased cardiac function.
For more information, visit perjeta.com or call 855-737-5382.
On Nov. 22, the FDA approved expanding the use of Nexavar (sorafenib) to treat patients with advanced differentiated thyroid cancer.
The approval was based on a clinical trial in which 417 participants with differentiated thyroid cancer that hadn’t responded to radioactive iodine treatment were randomly assigned to receive either Nexavar or a placebo. Median progression- free survival for those taking Nexavar was 10.8 months compared with 5.8 months for those taking the placebo. There was no significant difference in overall survival between the two groups.
Side effects included diarrhea, fatigue, hair loss and infection. For more information, visit nexavar.com or call 866-639-2827.
On Sept. 6, the FDA expanded the use of Abraxane (nab-paclitaxel) to include treating patients with advanced pancreatic cancer.
Often, pancreatic cancer is diagnosed in later stages and when surgery, which is currently the only curative treatment for the disease, is no longer an option. Abraxane, in combination with gemcitabine, is approved for patients with pancreatic cancer that has spread.
The combination was approved following a clinical trial in which 861 participants were randomly assigned to receive either the Abraxane-gemcitabine combination or gemcitabine alone. Those who took the combination had, on average, a 1.8-month delay in tumor growth and lived 1.8 months longer than those taking gemcitabine alone.
Common side effects included fever, vomiting, nausea, decreased white blood cells, hair loss, diarrhea, rash, fatigue, swelling of the feet and legs, dehydration and nerve damage.
For more information, visit abraxane.com or call 888-423-5436.
The generic version of Xeloda (capecitabine) was approved by the FDA on Sept. 16 to treat metastatic breast and colorectal cancers. In order to be approved by the FDA, generic drugs must meet the same quality and strength standards as their brand-name counterparts.
Patients also taking a blood-thinner, such as warfarin, should be aware that capecitabine can potentially boost the effects of such drugs, sometimes with serious side effects.
Common side effects include pain, diarrhea, vomiting, nausea, redness of the hands and feet, fever, serious skin reactions and infection.
The FDA has asked the manufacturer of Iclusig (ponatinib) to suspend marketing and sales due to reports of patients experiencing serious blood clots and severe narrowing of blood vessels while taking the drug.
The drug is approved to treat patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia who have experienced disease progression or who could not tolerate prior therapies.
While the drug’s label carried a strong boxed warning about the risk of blood clots, recent clinical trial data indicated that a higher percentage of patients (at least 20 percent) experienced blood clots or narrowing of blood vessels than previously reported.
Patients taking Iclusig are advised to speak with their doctors about the risks and benefits of continuing treatment with the drug. The FDA also recommends that patients experiencing symptoms suggesting a heart attack or a stroke seek immediate medical attention.