The latest in cancer prevention, diagnosis and treatment.
New Class of Drug Debuts with Melanoma Treatment
With the Sept. 4 approval of Keytruda (pembrolizumab) for advanced melanoma, the monoclonal antibody became the first treatment approved in a new drug class called PD-1 inhibitors. Keytruda blocks the PD-1 pathway, by which cancer cells can evade the immune system. The drug makes it possible for T cells to identify and attack melanoma tumors.
After being granted breakthrough status last year and then priority review in May, the Food and Drug Administration (FDA) gave Keytruda (also known as MK-3457) accelerated approval in early September after the agency determined the drug’s safety and potential effectiveness filled an unmet need for patients. Previous early-phase studies found the drug to be very safe and effective in shrinking tumors for several months. Follow-up studies are being conducted to confirm whether there is a survival benefit.
The drug is approved for patients with advanced or unresectable melanoma that no longer responds to other treatments, including Yervoy (ipilimumab). The approval marks the sixth new melanoma treatment since 2011.
Keytruda is one of several treatments that boosts the immune system. Additional studies are testing various combinations of these drugs, and researchers are hoping that targeting different pathways may boost survival even more. Other PD-1 inhibitors, as well as those that block PD-L1, are being tested in a variety of cancers, including lung and kidney cancers. For more information, visit keytruda.com or call 855-398-7832.
Avastin Approved for Use in Cervical Cancer
On Aug. 14, the FDA approved Avastin (bevacizumab) for women with recurrent, persistent or metastatic cervical cancer. Avastin is the first biologic drug to be approved for advanced cervical cancer, a mere four months after it was accepted in the FDA’s priority review program.
The approval was based on a study of 452 participants who were randomized to receive two different chemotherapy regimens with or without Avastin. The addition of Avastin improved overall survival from 12.9 months to 16.8 months, regardless of chemotherapy regimen. Researchers noted in their study results that patients with advanced cervical cancer usually do not have sustained responses to chemotherapy, the standard of care for this disease. Given the aggressive nature of advanced cervical cancer, an improvement of nearly four months is considered meaningful.
Some trial participants treated with Avastin, a therapy that disrupts the blood supply to tumors, experienced hypertension, fatigue and decreased appetite. Rare but severe occurrences of gastrointestinal perforations and fistulas were reported with the treatment.
New Screening Test for Colorectal Cancer
On Aug. 11, the FDA approved Cologuard, an at-home colorectal cancer screening test, the first stool-based test to use a particular noninvasive method in detecting colorectal cancers and potentially cancerous polyps.
The approval was based on a study of more than 10,000 individuals who were at average risk of colorectal cancer and between the ages of 50 and 85 years old. The participants used either Cologuard or another type of stool test called a fecal immunochemical test. Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced large polyps, compared with 74 percent and 24 percent, respectively. However, Cologuard. a gene-based test, did have a higher number of false positives, incorrectly identifying people who were negative for cancer or large polyps called adenomas (87 percent versus 95 percent).
While the test accurately detects potential cancer, individuals who have a positive result would need to undergo a colonoscopy to confirm the polyp or cancerous mass. For more information, visit cologuardtest.com or call 844-870-8870.
Zydelig Approved for Three Blood Cancers
On July 23, the FDA approved Zydelig (idelalisib) to treat patients with relapsed forms of three blood cancers: chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma and small lymphocytic lymphoma, another type of non- Hodgkin lymphoma. In trial, participants with CLL who were treated with Zydelig lived 10.7 months without disease progression compared with 5.5 months for those not taking the drug. Zydelig is the first approval of a P13 kinase inhibitor, and carries a warning to patients and doctors of fatal and serious side effects, including liver toxicity, diarrhea and colon inflammation, lung inflammation and intestinal perforation.
For details, visit zydeligrems.com.
Leukemia Drug Granted Expanded Use
On July 28, the FDA approved an expanded use of Imbruvica (ibrutinib) to treat patients with the 17p deletion form of chronic lymphocytic leukemia (CLL). Patients with CLL who carry the deletion in chromosome 17 generally respond poorly to standard treatment for CLL. The approval followed promising results from a clinical trial of 127 participants who had CLL with 17p deletion. Trial subjects were given Imbruvica or the standard therapy of Arzerra (ofatumumab). The trial was stopped early for effectiveness when it was determined that the group treated with Imbruvica experienced a significant reduction in the risk of disease progression or death.
Imbruvica is already approved for use in the second-line treatment of mantle cell lymphoma and CLL. It blocks an enzyme that allows cancer cells to grow and divide.
Because some healthy cells also use the enzyme, there are side effects, including low platelet counts (thrombocytopenia); a decline in white blood cells called neutrophils, which fight infection (neutropenia); diarrhea; anemia; and fatigue.
For additional information, visit imbruvica.com or call 877-877-3536.
Peripheral T-Cell Lymphoma Drug OK'd
Until recently, available treatments had limited success against peripheral T-cell lymphoma (PTCL), a diverse group of aggressive and rare cancers that attack lymph nodes. But on July 3, the FDA granted accelerated approval to Beleodaq (belinostat), because it filled an unmet need for patients with a serious condition.
The approval was based on a clinical trial of 129 people whose cancers either did not respond to other treatment or came back after other treatment. In about a fourth of those participants, cancers shrank or disappeared entirely with Beleodaq. On average, treatment response continued for just longer than eight months, but endured nearly 30 months in some participants. Beleodaq is in a class of drugs called histone deacetylase inhibitors. Side effects included nausea, vomiting, fatigue, fever, anemia, thrombocytopenia, neutropenia and infection. For more information, visit sppirx.com or call 702-835-6300.