Lindsay Ray

On April 29, the Food and Drug Administration (FDA) gave accelerated approval to Zykadia (ceritinib) to treat patients with a subtype of advanced non-small cell lung cancer (NSCLC) that has previously been treated with Xalkori (crizotinib). Specifically, Zykadia inhibits the mutated protein anaplastic lymphoma kinase (ALK), which is caused by a genetic abnormality present in 2 to 7 percent of NSCLC patients and can lead to the growth of abnormal cells.

Xalkori was the first drug approved for ALK-positive lung tumors and has since become a standard of care for this patient population. However, once patients become resistant to the drug, there has been no other approved therapy to offer them until now.

The drug’s safety and effectiveness were established in a trial of 163 participants with Xalkori-resistant, ALK-positive NSCLC. All participants received Zykadia, and about half of the participants had their tumors shrink, a result that lasted for a median of approximately seven months.

Previously, Zykadia had received a breakthrough therapy designation, which is designed to speed promising therapies through the review process. It was only the fourth drug to receive this designation.

Common side effects were mostly gastrointestinal, such as diarrhea, abdominal pain, nausea and vomiting. Increased liver and pancreatic enzymes and glucose levels were also observed.

The FDA approved a new form of an old drug for acute lymphoblastic leukemia (ALL) on April 28. Purixan (mercaptopurine) is approved to treat patients with ALL in combination with other agents.

Purixan is an oral suspension, whereas the older approved form of mercaptopurine is a tablet. Mercaptopurine is commonly used to treat ALL, but the tablet form is not ideal for treating children, often because dose adjustments are difficult or the pills are hard to swallow. However, Purixan should make it easier to accurately adjust doses.

The approval is based on a trial that confirmed Purixan had the same bioequivalence as the mercaptopurine tablets, which meant that both formulations were equally absorbed by the body.

Common side effects included low platelet and red and white blood cell counts, so patients should be monitored with a complete blood count, and should levels get too low, dose adjustments might be necessary.

The first drug to treat patients with multicentric Castleman’s disease (MCD) received FDA approval on April 23. MCD, which involves excessive growth of immune cells in the lymph system and acts similarly to lymphoma, can develop into lymphoma.

Sylvant (siltuximab) inhibits a protein that triggers the immune cells’ abnormal growth. The drug’s safety and effectiveness was established in a clinical trial involving 79 participants who were randomly assigned to receive best supportive care with or without Sylvant. About a third of those receiving Sylvant had a durable tumor and symptom response, whereas no one receiving best supportive care and placebo had a response.

Side effects included itchy skin, rash, upper respiratory tract infection and weight gain.

The FDA has approved the cobas HPV test to determine whether women age 25 and older need further testing or might be at risk for cervical cancer.

The cobas HPV test was previously approved in 2011 to be used with or after a Pap test, and although the new approval doesn’t replace current guidelines, it does extend the test’s use to include co-testing or as a primary screening tool for cervical cancer.

The test detects DNA from 14 high-risk types of human papillomavirus (HPV), including HPV 16 and HPV 18, which account for about 70 percent of cervical cancers. Those who test positive for HPV 16 and 18 should have a colposcopy and those who are positive for the other high-risk types should have a Pap test to see if additional testing is warranted.

On April 21, the FDA approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or cancer at the juncture of the esophagus and stomach, called gastroesophageal junction (GEJ) adenocarcinoma. The drug is indicated for patients with inoperable cancers or those with metastatic disease after treatment with platinum- or fluoropyrimidine-based chemotherapy.

Cyramza is the first approved single-agent treatment for patients after their stomach cancer has progressed following initial therapy.

The approval was based on results from an international phase 3 study in which 355 previously treated participants with either stomach cancer or GEJ were randomly assigned to receive Cyramza or best supportive care. Cyramza improved median overall survival by 1.4 months compared with placebo.

Common side effects of Cyramza included diarrhea and high blood pressure. For details, call 800-545-5979.

On April 17, the FDA granted full approval for Arzerra (ofatumumab) in combination with Leukeran (chlorambucil), expanding the indication to include previously untreated patients with chronic lymphocytic leukemia (CLL) who cannot receive fludarabine- based therapy. Arzerra was previously approved to treat patients with CLL who no longer respond to fludarabine and Campath (alemtuzumab).

The full approval comes after a post-marketing trial confirmed the benefit of Arzerra, which had previously been granted accelerated approval. In the open-label study, 447 participants took Arzerra and Leukeran or Leukeran alone, with those on the combination experiencing improved progression-free survival: 22.4 months compared with 13.1 months.

Common side effects of the combination included infusion reactions, pain in the joints and abdomen and low white blood cell count.

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joined a group of Australian female singers to honor 

 dying wish: that the rock group Divinyls’ hit song “I Touch Myself” become a breast cancer anthem. Amphlett, the group’s lead vocalist, died from complications of breast cancer and multiple sclerosis in April 2013. Since then, her husband and several vocalists, including the late singer’s cousin Little Pattie, turned her dream into a reality, gathering to record an a cappella version of the song and create a music video to raise awareness about breast self-exams. Amphlett discovered her breast cancer during a self-exam.

, has completed chemotherapy and her cancer is in remission. In late 2013, after a failed pregnancy, Arnold announced that she had received a diagnosis of choriocarcinoma, a rare form of cancer that develops in cells that normally form the placenta in pregnancy. The show also documented Arnold’s cancer experience.

, 43, died on April 19 from complications of past stomach surgeries and digestive system problems. As a young adult, Sharp was treated for Ewing’s sarcoma, a form of bone cancer. During that time, the Make-A-Wish Foundation granted his wish to meet Grammy award-winning producer David Foster, who later helped Sharp with his career. Best known for country hits, including “Nobody Knows,” Sharp also wrote a book about his cancer experience.

 revealed he had received a diagnosis of multiple myeloma in August 2013. During an appearance on 

, Brokaw said he was “very pleased with the progress” of his treatment, yet admitted he has access to better health care than many people.

The Divinyls' lead singer, Chrissy Amphlett, died in April, but her wish to have "I Touch Myself" become a breast cancer anthem was honored by other music artists.

Hit Song Becomes Breast Cancer Anthem

On April 29, the Food and Drug Administration (FDA) granted accelerated approval to Zykadia (ceritinib) to treat patients with a subtype of advanced non-small cell lung cancer (NSCLC).Zykadia inhibits the mutated protein anaplastic lymphoma kinase (ALK), which is caused by an abnormality in the ALK gene and can promote abnormal cell growth. This abnormality is present in 3-7 percent of patients with NSCLC. Zykadia is specifically approved to treat patients with this abnormality who no longer respond to Xalkori (crizotinib), which is also approved to treat ALK-positive NSCLC patients.Xalkori was the first drug approved for ALK-positive lung tumors and has since become a standard of care for this patient population. However, once patients become resistant to the drug, there has been no other approved therapy to offer them until now.Zykadia's safety and effectiveness were established in a trial of 163 participants with Xalkori-resistant, ALK-positive NSCLC. All participants received Zykadia, and about half of the participants had their tumors shrink, a result that lasted for a median of approximately seven months.This decision comes four months before the review deadline. The accelerated approval review process allows patients earlier access to promising drugs while the manufacturer conducts confirmation trials. Zykadia was also given a breakthrough therapy designation, which is also designated to speed promising therapies through the review process, and is the fourth drug to be approved with this designation. (You can read more about this new designation 

.)Common side effects are mostly gastrointestinal, including diarrhea, abdominal pain, nausea and vomiting. Increased liver and pancreatic enzymes and glucose levels might also occur.For more information, visit 

 or call 888-669-6682.And for more information on lung cancer and genetic abnormalities, read CURE's Spring 2014 feature "

Research Reveals New Frontiers in Lung Cancer

New drug for non-small cell lung cancer

On Monday, April 21, the Food and Drug Administration approved Cyramza (ramucirumab) to treat patients with advanced stomach cancer or cancer where the esophagus meets the stomach (gastroesophageal junction adenocarcinoma). This approval includes patients with inoperable cancers and those with metastatic disease after treatment with platinum- or fluoropyrimidine-based chemotherapy.Cyramza is a type of drug known as an angiogenesis inhibitor, which means it blocks the tumor's blood supply. This past October, the therapy was given priority review status (meaning the FDA would make a decision within six months) after promising clinical trial results and because it met an unfilled need. This approval makes Cyramza the first approved single-agent treatment for stomach cancer after it has progressed following initial therapy.The FDA based the approval on results from the REGARD trial, an international, phase 3 study in which 355 previously treated patients with either stomach cancer or gastroesophageal junction adenocarcinoma were randomly assigned to receive either Cyramza or best supportive care. Treatment with Cyramza improved median overall survival by 1.4 months compared with those receiving placebo.Earlier this year, data from another study pointed to further benefits of Cyramza therapy. The phase 3 RAINBOW trial looked at adding Cyramza to paclitaxel when treating these diseases after prior therapy. The combination extended median overall survival to 9.63 months compared with 7.36 months for patients who received paclitaxel plus placebo. Furthermore, the combination of Cyramza and paclitaxel also prolonged progression-free survival: 4.4 months compared with 2.86 months.Common side effects of Cyramza include diarrhea and high blood pressure. For more information, call 800-545-5979.

Lindsay Ray

Pipeline

Hit Song Becomes Breast Cancer Anthem

New drug for non-small cell lung cancer

FDA approves new drug for gastric cancer

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