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Pipeline

The latest in cancer prevention, diagnosis & treatment.

BY Lindsay Ray
PUBLISHED June 18, 2013

The Food and Drug Administration (FDA) approved Xofigo (radium-223) on May 15—more than three months ahead of schedule—to treat patients with castration-resistant prostate cancer and symptomatic bone metastases but no metastases to other organs. Patients must have been previously treated with a form of testosterone-lowering therapy.

Xofigo is an injectable drug, given every four weeks for six doses, that chemically binds to the bone mineral to deliver radiation directly to the site of metastases.

The approval is based on an 809-participant trial in which men received either Xofigo and best standard care or placebo and best standard care. Those on Xofigo had a median overall survival of 14 months compared with 11.2 months for those on the placebo. Participants in the Xofigo arm also had a longer time to the onset of an adverse skeletal event. 

Common side effects included nausea and vomiting, diarrhea and low red cell, white cell and platelet counts.

For details, call 855-696-3446 or visit xofigo.com.

On May 14, the FDA approved Tarceva (erlotinib) for expanded use in non-small cell lung cancer (NSCLC). It can now be used as a first-line therapy to treat patients with metastatic disease and certain epidermal growth factor receptor (EGFR) gene mutations.

A companion diagnostic test, the cobas EGFR Mutation Test, was also approved to detect the EGFR mutations, which occur in 10 percent of NSCLC cases. NSCLC is the most common type of lung cancer, accounting for about 85 percent of the estimated 228,000 new cases annually.

The safety and effectiveness of the test were established from clinical data that showed patients with NSCLC and certain EGFR mutations who received Tarceva lived 10.4 months without disease progression, compared with 5.4 months for patients who received the standard two-drug chemotherapy.

For details, call 877-827-2382 or visit tarceva.com.

In March, the FDA approved the injectable, radioactive agent Lymphoseek (technetium Tc 99m tilmanocept) to be used in lymph node mapping in patients who have breast cancer or melanoma and are undergoing surgery to remove tumor-draining "sentinel" nodes.

Lymph nodes filter the fluid that flows from tissues into the lymphatic system, which branches throughout the body and produces and carries infection-fighting white blood cells. This fluid can contain cancer cells if it drains from an area near a tumor. Sometimes sentinel nodes show the first signs of cancer spreading, so doctors remove and examine these nodes in an effort to avoid a full node dissection, which can lead to lymphedema, a condition caused by blockage in the lymphatic system.

The drug’s safety and effectiveness were established in a trial of 332 participants that compared blue dye, also used to find lymph nodes, with Lymphoseek. Both identified most lymph nodes, but some nodes were found by Lymphoseek alone.

On May 29, the FDA approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), to treat metastatic melanoma or melanoma that cannot be surgically removed. Each drug is approved as a single-agent therapy.

Although they work slightly differently, both drugs treat tumors that have mutations in the BRAF gene. Tafinlar treats those with the BRAF V600E mutation, and Mekinist treats those with this mutation or the BRAF V600K mutation. The companion diagnostic test, THxID BRAF test, helps to identify whether a patient has these genetic mutations. BRAF mutations are found in about half of melanomas.

Tafinlar was approved based on a study in which 250 participants with the BRAF V600E mutation were given Tafinlar or dacarbazine. Those on the Tafinlar arm had an improved progression-free survival of 2.4 months longer than those on the dacarbazine arm.

Approval for Mekinist came after a trial of 322 participants showed an increase in progression-free survival for those treated with the drug. Participants with the BRAF V600E and V600K mutations were randomly assigned to receive either Mekinist or chemotherapy, and those on Mekinist had a 3.3-month longer progression-free survival.

The companion test approval is based on data from these studies.

Common side effects of Tafinlar include hair loss, joint pain and skin issues. 

Common side effects of Mekinist include diarrhea, rash and other skin issues.

For additional information on either drug, call 888-825-5249.

On June 5, the FDA approved Revlimid (lenalidomide) to treat patients with mantle cell lymphoma (MCL) that have relapsed or progressed following two previous therapies, including Velcade (bortezomib). MCL is a type of non-Hodgkin lymphoma that while slow-growing, can be difficult to treat.

Revlimid is a pill that has previously been approved to treat multiple myeloma and myelodysplastic syndrome.

Approval was based on safety and efficacy established in a 134-patient clinical trial. All patients with MCL had received previous treatment with Velcade and relapsed or had refractory disease. Nine patients had a complete response (no evidence of disease), and 25 patients had a partial response (a decrease in cancer in the body).

The most common side effects include low blood cell and platelet counts, fatigue and diarrhea.

For more information, visit revlimid.com or call 800-931-8691.

New, firmer silicone breast implants, called MemoryShape Breast Implant, were approved by the FDA on June 14 for breast reconstruction in women of all ages. The implant was also approved for breast augmentation in women 22 and older.

Including this approval, there are now five FDA-approved silicone gel-based breast implants. The safety of the latest implant was established from six years of data from 955 women. Complications and outcomes were similar to other implants, with complications including re-operation, removing the implant, skin tightening around the implant and asymmetry. Cracks also appeared in the gel of some of MemoryShape implants.

The FDA is also requiring more data post-approval, which will come from continuing to follow the 955 women who already have the implants and six new studies that look at long-term complications and potential risk for rare diseases.

In early June, the FDA announced that it would not approve the drug tivozanib for renal cell carcinoma (kidney cancer). This follows the Oncologic Drugs Advisory Committee’s vote of 13 to 1 against approval back in May.

The drug was submitted to the agency based on the results of a phase 3 trial comparing the drug with the already FDA-approved Nexavar (sorafenib). Of the 517 patients in the trial, tivozanib demonstrated a 2.8-month improvement in progression-free survival. However, there was no overall survival benefit, and in fact, those on Nexavar lived marginally longer.

The FDA suggested further follow-up studies, but the drug manufacturer has decided to focus on tivozanib in breast and colorectal cancers.

On Jan. 25, the FDA extended the approval for Gleevec (imatinib), in combination with chemotherapy, to treat children with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

ALL is one of the most common cancers in children, 3 out of 4 cases of leukemia in children and teens are ALL. Children with the Philadelphia chromosome mutation produce an enzyme called tyrosine kinase that promotes the proliferation of abnormal white blood cells, which can build up and crowd out the normal, healthy cells. Gleevec works by blocking this tyrosine kinase.

The new indication was approved based on a trial with 92 patients who were at least 1 year old and had high-risk ALL. Patients were placed into five treatment groups, with each group receiving a higher duration of Gleevec in combination with chemotherapy. Of the patients who received the longest duration of Gleevec, 70 percent did not experience disease relapse or death within four years, and the number of deaths decreased with increasing duration of Gleevec and chemotherapy.

Common side effects included neutropenia, low levels of platelets and liver toxicity. Stunted growth has also been reported in some children taking Gleevec.

For more information, visit gleevec.com or call 888-669-6682.

The FDA approved an Avastin (bevacizumab)-based second-line therapy for treating patients with metastatic colorectal cancer (mCRC). Avastin is already approved to treat mCRC in the first-line setting and in the second-line setting in combination with 5-FU (fluorouracil)-based chemotherapy. Fluoropyrimidines include Xeloda (capecitabine), floxuridine and 5-FU (fluorouracil).

Approval was based on a phase 3 trial with 820 patients with mCRC who had progressed during or following treatment with Avastin-based chemotherapy. Patients were randomly assigned to chemotherapy plus Avastin or chemotherapy alone. Patients in the Avastin arm had a median overall survival of 11.2 months compared with 9.8 months for those in the chemotherapy-only arm. Progression-free survival was also improved by a median of 1.7 months for those in the Avastin arm.

The side effects in this study were similar to those seen in previous studies, which included fatigue, diarrhea and mouth sores.

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