A look at 10 of the most significant advances of the past year—progress that stands to benefit patients now and lays the foundation for future breakthroughs
Patients with chronic lymphocytic leukemia (CLL) are among the biggest beneficiaries of progress in cancer treatment in 2015. The US Food and Drug Administration (FDA) has approved new treatments for both those with untreated and previously treated CLL. Importantly, these new therapies are easier to tolerate, which means potential options for patients who have been unable to tolerate standard CLL therapies.
For Patients with Previously Untreated Chronic Lymphocytic Leukemia
Gazyva® (obinutuzumab) was approved for use in combination with Leukeran® (chlorambucil) in people with previously untreated CLL in late 2013. In 2015 the FDA updated the approval of Gazyva plus Leukeran with a supplemental biologics license application (sBLA)—a submission that contains specific information about the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects of the biologic product. The sBLA for Gazyva plus Leukeran included the following information about improved survival for patients with CLL:1
- Gazyva plus Leukeran helped people with previously untreated CLL live nearly a year longer without a worsening of disease compared with the standard CLL treatment Rituxan® (rituximab) plus Leukeran.
- With Gazyva plus Leukeran, nearly three times the number of people had a complete response compared with Rituxan plus Leukeran.
This past year the FDA also issued an sBLA for Arzerra® (ofatumumab) in combination with Leukeran in previously untreated patients with CLL—specifically for patients who are not candidates for treatment with chemotherapy that contains the drug Fludara® (fludarabine).2
This most recent approval of Arzerra (a monoclonal antibody that targets a molecule known as CD20, which is found on the surface of B-cells) was based on the results of a Phase II trial. The multicenter, randomized, open-label trial included 447 patients for whom Fludara-based therapy was considered inappropriate (because of advanced age or other health conditions). Researchers randomly selected patients to receive Arzerra plus Leukeran or Leukeran alone.
Patients who received Arzerra plus Leukeran had a significantly improved median progression-free survival compared with those who received Leukeran alone (22 months versus 13 months).
For Patients with Previously Treated Chronic Lymphocytic Leukemia
While the approvals for both Gazyva and Arzerra stand to benefit patients with untreated CLL, there is also important progress for patients with previously treated CLL. Two biological therapies that block the growth of cancer—Imbruvica® (ibrutinib) and Zydelig® (idelalisib)—demonstrated important survival improvements for these patients.3,4
In a multicenter trial of 48 patients with previously treated CLL and an average age of 67 years, patients who received Imbruvica had an overall response rate of 58 percent. These responses lasted from about six to 24 months.
Zydelig also proved safe and effective for the treatment of previously treated CLL, based on findings from a clinical trial that included 220 patients. Participants were assigned treatment with Zydelig and Rituxan or with a placebo and Rituxan. At the first planned follow-up, the researchers found that participants treated with Zydelig and Rituxan lived almost 11 months without disease progression compared with about six months for those treated with placebo and Rituxan. At the next follow-up, they continued to see significant survival benefits with Zydelig and Rituxan over placebo and Rituxan.
(http://news.cancerconnect.com/promising-advances-for-patients-with-chronic-lymphocytic-leukemia/#_ednref1 "1") FDA approves Gazyva for chronic lymphocytic leukemia [news release]. US Food and Drug Administration website. Available at: [http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm](http:// www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm373209.htm). Accessed October 16, 2015.
(http://news.cancerconnect.com/promising-advances-for-patients-with-chronic-lymphocytic-leukemia/#_ednref2 "2") GSK and Genmab receive FDA approval for Arzerra® (ofatumumab) as first-line treatment in combination with chlorambucil for patients with Chronic Lymphocytic Leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate [news release]. GlaxoSmithKline website. Available at: [http://www.gsk.com/ media/press-releases/2014/gsk-and-genmab-receive-fda-approval-for-arzerra-ofatumumab. html.](http://www.gsk.com/ media/press-releases/2014/gsk-and-genmab-receive-fda-approval-for-arzerra-ofatumumab. html.) Accessed October 16, 2014.
(http://news.cancerconnect.com/promising-advances-for-patients-with-chronic-lymphocytic-leukemia/#_ednref3 "3") FDA expands approved use of Imbruvica for chronic lymphocytic leukemia. US Food and Drug Administration website. Available at: [http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm406916.htm.](http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm406916.htm.) October 16, 2015.
(http://news.cancerconnect.com/promising-advances-for-patients-with-chronic-lymphocytic-leukemia/#_ednref4 "4") FDA approves Zydelig for three types of blood cancers. US Food and Drug Administration website. Available at: [http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ ucm406387.htm.](http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ ucm406387.htm.) Accessed October 16, 2015.
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