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Pipeline

News on clinical trial results, drug approvals and updates on therapies.

BY Lindsay Ray
PUBLISHED March 08, 2014

On Jan. 10, the Food and Drug Administration (FDA) granted accelerated approval to the first combination treatment for melanoma that can’t be treated surgically or has metastasized.

Mekinist (trametinib) and Tafinlar (dabrafenib) are approved to treat patients with melanoma that have genetic BRAF V600K and V600E mutations. The BRAF gene is mutated in approximately half of skin melanomas.

Both Tafinlar and Mekinist were approved by the FDA this past May as single-agent therapies. They are kinase inhibitors that work by targeting different areas of the same cell growth pathway. Both are taken orally.

The approval is based on a 162-participant trial, in which subjects with the BRAF mutations were randomized to receive the drug combination or Tafinlar alone. Seventy-six percent of participants receiving the combination had their cancer shrink or disappear, compared with 54 percent on Tafinlar alone. Those in the combination arm also had their response last for a median of 4.9 months longer. While there are no data about survival yet, the accelerated approval is contingent upon the survival data following the completion of the ongoing MEK115306 trial.

Common side effects included fever, nausea and vomiting, edema and joint pain. Serious side effects included bleeding, severe fever and kidney failure. Mekinist and Tafinlar may cause infertility. However, a serious side effect associated with Tafinlar, developing squamous cell skin cancer, was reduced for those receiving the combination—7 percent compared with 19 percent on Tafinlar alone.

For more details on either drug, call 888-825-5249.

After the manufacturer of Iclusig (ponatinib) suspended marketing of the blood cancer drug because of the risk of life-threatening blood clots and narrowing of blood vessels, the FDA has said the company can resume marketing—with several new safety measures in place.

Safety measures include updating the label to list specific warnings about the vascular events and new information on decreasing the dosage and discontinuing the drug. The patient Medication Guide (a paper handout that can help patients avoid serious side effects) has also been updated to reflect this information, and a risk evaluation and mitigation strategy for healthcare providers has been added.

The indication for the drug has also been narrowed to include only adult patients with T315I-positive chronic myeloid leukemia (CML) in any phase (which is resistant to the commonly used drug Gleevec [imatinib]) or T315I-positive, Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) or those with CML or Ph+ ALL for which there is no other tyrosine kinase inhibitor.

For more information, visit iclusig.com or call 855-552-7423.

On Feb. 12, the FDA approved Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) after at least one prior therapy, expanding Imbruvica’s use beyond the previous recent approval for patients with mantle cell lymphoma.

The approval is based on a study of 48 participants with previously treated CLL who all received Imbruvica. Tumors shrank after treatment in 58 percent of participants, with the response lasting several months for some. There are no data on improved survival or better disease-related symptoms yet.

Common side effects included low blood cell levels, diarrhea, musculoskeletal pain, rash, fever, constipation, nausea and fatigue.

For details, visit imbruvica.com or call 877-877-3536.

In November, the FDA approved a delayed-release tablet version of Noxafil (posaconazole) for prevention of invasive fungal infections caused by Aspergillus or Candida. These types of infections can occur in patients who have suppressed immune systems, which can result from certain cancer treatments. Noxafil is approved for those who have had a hematopoietic stem cell transplantation and have developed graft-versushost disease or patients with blood cancers who are experiencing neutropenia following chemotherapy. Noxafil was previously approved in an oral liquid formulation.

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