Pipeline

The Food and Drug Administration approved Adcetris (brentuximab vedotin) on Aug. 19 for Hodgkin lymphoma patients who have relapsed after an autologous stem cell transplant and for patients with relapsed or resistant systemic anaplastic large cell lymphoma (ALCL). Adcetris, the first drug approved for Hodgkin lymphoma since 1977, received a unanimous FDA advisory committee recommendation for accelerated approval and priority review on July 14.

On Aug. 17, the FDA approved Zelboraf (vemurafenib) for patients with the BRAF V600E gene mutation who have metastatic or unresectable melanoma. The accompanying diagnostic test, cobas 4800 BRAF V600 Mutation Test, was also approved to determine if patients carry this genetic mutation. Zelboraf’s approval comes after an international trial found that patients on the drug had improved overall survival compared with patients receiving dacarbazine (6.2 and 4.5 months, respectively).

Patients taking Zelboraf should avoid sun exposure, as the most common adverse effects include skin sensitivity to sunlight, as well as joint pain and rash. About 25 percent of patients developed cutaneous squamous cell carcinoma that was managed with surgery. For details, visit zelboraf.com or call 888-249-4918.

The FDA approved Xalkori (crizotinib), a treatment for late-stage non-small cell lung cancer (NSCLC) patients with the abnormal anaplastic lymphoma kinase (ALK) gene, along with a companion diagnostic test to detect the ALK gene, on Aug. 26. This particular subset of NSCLC affects 6,500 to 11,000 patients a year. The approval was based on two studies that showed complete or partial tumor shrinkage in more than half of patients. Follow-up trials will be conducted. Common side effects include vision disorders, nausea and diarrhea. For details, visit xalkori.com or call 877-744-5675.

A new genetic test, approved by the FDA on June 14, will help professionals determine whether women have HER2-positive breast cancer and thus are candidates for Herceptin (trastuzumab). About 20 percent of all breast cancers are HER2-positive.

The test, Inform Dual ISH, works by allowing lab technicians to view a small, stained sample of the breast tumor directly under a standard microscope for longer periods of time than the traditional testing method, which requires the use of fluorescence microscopes. The technicians are then able to count the average number of copies of the HER2 gene per cell.

On June 30, the FDA approved Lazanda (fentanyl) nasal spray for breakthrough pain in adults who have developed a resistance to their current opioid therapy. Breakthrough pain is a rapid-onset, intense episode of pain, even when pain medication is being used.

Lazanda’s efficacy was established through randomized clinical trials involving more than 500 adult cancer patients who were receiving adequate background opioid therapy and experiencing breakthrough pain. Researchers looked at the average pain intensity after 30 minutes and found that it was significantly improved for those taking the nasal spray compared with a placebo. Common side effects included vomiting, nausea, fever and constipation. Opioid non-tolerant patients should not take Lazanda as there could be life-threatening side effects.

For more information, visit lazanda.com.

Adcetris works by combining an antibody that targets the CD30-positive Reed-Sternberg cells with the chemotherapy drug monomethyl auristatin E (MMAE). The approval was based on a phase 2 trial in which one-third of patients experienced complete remission. Also, 94 percent of patients had tumor shrinkage that lasted a median of 29 weeks. 

Fifty-two percent of patients in the study experienced peripheral sensory neuropathy, which became more manageable for most patients after the drug was stopped or treatment completed. Other side effects include fatigue, nausea, upper respiratory tract infection and diarrhea. For details, visit adcetris.com or call 855-473-2436.

On June 10, the FDA approved a machine that allows for a PET (positron emission tomography) and MRI (magnetic resonance imaging) scan to be performed at the same time. The FDA has already approved two-in-one PET and CT (computerized tomography) scans, but CT scans carry the potential for DNA damage due to X-rays. The agency notes the combined MRI-PET scans would especially benefit children, who are susceptible to radiation exposure, and patients who undergo multiple scans.

On June 17, the FDA approved a new dosage regimen for Lupron Depot (leuprolide acetate for depot suspension). The 45 mg six-month formulation of Lupron Depot joins the already approved one-month, three-month and four-month versions as hormonal treatment of advanced prostate cancer.

The drug works by suppressing the production of testosterone, which can help hormone-dependent cancer cells to grow. The six-month version allows for more dosing flexibility and was approved after a 48-week, 151-patient study showed testosterone suppression was sustained throughout the entire treatment period. Common side effects include hot flashes and injection site pain. Long-term treatment can affect the heart’s electrical activity.

For more information, visit lupron.com.