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Pipeline

The latest in cancer prevention, diagnosis and treatment.

BY Lindsay Ray
PUBLISHED December 21, 2011

The Food and Drug Administration approved Erwinaze (asparaginase Erwinia chrysanthemi) on Nov. 18 for patients with acute lymphocytic leukemia (ALL) who have become hypersensitive to other standard Escherichia coli (E. coli)-derived treatments.

ALL is the most common form of childhood cancer, affecting around 2,900 kids and teens in the U.S. each year. Of those patients, 15 to 20 percent develop an allergy to Elspar (asparaginase injection) or Oncaspar (pegaspargase), which are approved for use in multi-agent regimens to treat ALL and are derived from E. coli.

The approval is based on a safety and efficacy trial of 58 patients and data from an expanded access program, which included 843 patients.

Side effects include serious allergic reactions, pancreatic inflammation, high levels of liver enzymes in the blood and clotting and bleeding.

For more details, visit erwinaze.com or call 888-837-4397.

On Nov. 16, the FDA approved Jakafi (ruxolitinib) to treat intermediate- or high-risk myelofibrosis, a rare form of chronic leukemia in which the body’s normal blood production is disrupted.

Although other myelofibrosis treatments are available, Jakafi is the first drug approved to specifically treat the disorder as well as the first approval for the JAK inhibitor drug class. Jakafi inhibits the enzymes Janus-associated kinase (JAK) 1 and 2, which are involved in regulating blood.

The approval is based on two phase 3 trials that evaluated 528 patients. In both trials, more patients experienced greater reduction in spleen volume (an enlarged spleen is a side effect of myelofibrosis) and improvement of symptoms (but not an improvement in blood counts, which are often affected by myelofibrosis).

Serious side effects include low platelet levels (thrombocytopenia) and anemia.

For more details, visit jakafi.com or call 855-452-5234.

On Nov. 8, the FDA approved Erbitux (cetuximab) for treating patients with late-stage head and neck cancers in combination with chemotherapy. The approval is based on an international, multicenter study that found Erbitux in combination with chemotherapy extended survival compared with those on chemotherapy alone.

Erbitux is already approved to treat EGFR-positive, late-stage colon cancer and as a first-line therapy with radiation and as a single agent after standard therapy for nonmetastatic squamous cell carcinoma of the head and neck.

Common side effects include rash, itching, nail changes, headache, diarrhea and infections. Erbitux is also associated with more serious side effects, such as infusion reactions and heart attack. Patients on Erbitux are also advised to limit sun exposure.

For details, visit erbitux.com or call 888-372-4889.

Prolia (denosumab) earned FDA approval on Sept. 16 to increase bone mass in patients who are at high risk for fracture and are receiving adjuvant aromatase inhibitor therapy for breast cancer or androgen deprivation therapy for nonmetastatic prostate cancer. The drug was previously approved to treat osteoporosis in postmenopausal women at high risk for fracture and is approved under the name Xgeva to prevent skeletal-related events in patients with bone metastases from solid tumors.

Prolia is a monoclonal antibody that blocks a protein called RANK ligand, which is essential to osteoclasts (cells that contribute to bone remodeling).

Side effects include joint and back pain. A rare but serious side effect is osteonecrosis of the jaw (bone death).

For details, visit prolia.com or call 877-477- 6542.

The FDA approved a new device on Nov. 2 to aid dermatologists in diagnosing melanoma. The device, MelaFind, takes digital pictures of skin lesions and uses a computer to compare them against a database of 10,000 archived images. The device then indicates whether a biopsy should be performed. Generally, doctors must diagnose melanoma based on visual cues, such as size, shape and color.

MelaFind usage is limited to board-certified dermatologists who have received training on the device and to look at suspicious growths that have one or two possible characteristics of melanoma. The company is expected to roll out the device next year to 200 dermatologists, who will lease and train on the devices. Patients will pay $150 for a MelaFind scan.

The FDA issued a new warning that Sprycel (dasatinib) may increase the risk of a rare, but serious side effect called pulmonary arterial hypertension (PAH), which is abnormally high blood pressure in the arteries of the lungs. Sprycel is approved to treat Philadelphia chromosome-positive chronic myeloid leukemia and acute lymphoblastic leukemia.

PAH can cause the heart to work harder to pump blood through the lungs, and as a result, the heart may weaken over time. Symptoms of PAH include shortness of breath, fatigue and swelling of the limbs. Problems have been reported in people taking Sprycel for more than a year and who were often taking other medications at the same time or had other co-existing medical conditions.

People who develop symptoms should notify their physician right away, and if PAH is confirmed, Sprycel should be discontinued.

On Oct. 25, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) recommended that boys between the ages of 11 and 12 get vaccinated against the human papillomavirus (HPV) as well as those between 13 and 21 who had not received all three doses required for vaccination.

Although the vaccine, Gardasil, has been approved for both males and females between ages 9 and 26, the CDC had only recommended females get vaccinated, with vaccinations for boys remaining optional. This step is significant because insurance companies often cover vaccines once the committee recommends them. The three-shot doses currently cost at least $300.

HPV is associated with cervical, anal and oropharyngeal cancers.

On Nov. 18, the FDA approved the removal of the bioscan requirement for Zevalin (ibritumomab tiuxetan), which is approved for use in patients with follicular non-Hodgkin lymphoma. Without the scan, the process for administering the drug is simplified and might allow more patients access to the treatment.

Prior to the FDA’s approval, patients would receive Rituxan (rituximab) on day 1 immediately followed by a diagnostic dose of radiolabeled Zevalin and then a full-body scan (the bioscan requirement) at a nuclear imaging center and again on day 3 or 4. Then patients would receive another dose of Rituxan and a therapeutic dose of Zevalin on day 7, 8 or 9.

Without the bioscan, patients can now receive two infusions of Rituxan followed by a dose of Zevalin.

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