FDA Broadens Ceritinib Indication to Previously Untreated ALK-Positive Metastatic NSCLC

Excerpt:

“On May 26, 2017, the U.S. Food and Drug Administration granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

“In April 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib based on a blinded independent review committee (BIRC)-assessed overall response rate (ORR) of 44% among 163 patients in a single-arm trial.”

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Brigatinib First to Offer over 1-Year Control of ALK-Positive Lung Cancer Post-Crizotinib

Excerpt:

“About 3-5 percent of lung cancers are caused by changes in the gene ALK. In 2011, the FDA granted accelerated approval for the drug crizotinib to target these ALK changes. However, two major problems have remained: Crizotinib does not pass into the brain and so is unable to target ALK-positive lung cancer in the central nervous system, and the genetic diversity of cancer allows the later growth of subpopulations that can resist the drug, leading to renewed growth. In response, researchers have been actively developing next-generation ALK-inhibitors.

“Results of a multi-center, 222-person phase 2 clinical trial of the next-generation ALK inhibitor, brigatinib at 180mg/day, used after failure of crizotinib showed a 54 percent response rate and 12.9 month progression-free survival. (Effects were lower at a lower dose.) Results are published in the Journal of Clinical Oncology.”

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FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer

Excerpt:

“On Friday evening, Takeda Pharmaceuticals announced the FDA has approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

“Brigatinib is a kinase inhibitor that can be taken orally. The recommended dose is 90 mg orally once daily for the first 7 days. If 90 mg is tolerated during the first 7 days, patient should increase the dose to 180 mg orally once daily. The pill can be taken with or without food.”

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FDA Grants Lorlatinib Breakthrough Designation for NSCLC

Excerpt:

“The FDA has granted a breakthrough therapy designation to lorlatinib for use in patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have previously received 1 or more ALK inhibitors, according to Pfizer, the company developing the next-generation ALK/ROS1 tyrosine kinase inhibitor (TKI).

” ‘This regulatory designation recognizes the potential for lorlatinib to provide an important treatment option for patients with ALK-positive NSCLC whose cancers have progressed despite treatment,’ Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development, said in a release. ‘Pfizer’s rapid development of lorlatinib reflects a commitment to developing biomarker-driven therapies to meet the evolving needs of patients.’ ”

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Roche’s Alecensa Beats Pfizer’s Xalkori in Lung Cancer Trial

Excerpt:

“Roche has presented late-stage data showing that its Alecensa was superior to Pfizer’s Xalkori on progression-free survival in patients with a specific type of lung cancer.

“The global, randomised Phase III ALEX study hit its primary endpoint in showing that Alecensa (alectinib) as a first-line treatment significantly reduced the risk of disease worsening or death (progression-free survival, PFS) versus Xalkori (crizotinib) in people with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).”

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Frontline Setting for ALK+ NSCLC Set to Undergo Shift

Excerpt:

“Currently available as a second-line therapy for patients with ALK-positive non–small cell lung cancer (NSCLC), alectinib’s (Alecensa) frontline potential is being explored in the ongoing phase III ALEX study (NCT02075840), which could transform first-line treatment for these patients.

“This study is comparing alectinib with crizotinib (Xalkori)—a current first-line option—in the frontline setting for patients with ALK-positive NSCLC. The oncology community is anticipating reports on the data in the first half of 2017.”

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FDA Grants Ceritinib Priority Review in Frontline ALK+ NSCLC

Excerpt:

“The FDA has granted a priority review to ceritinib (Zykadia) as a first-line treatment for patients with ALK-positive, metastatic non–small cell lung cancer (NSCLC), according to Novartis, the manufacturer of the second-generation ALK inhibitor.

“The priority review is based on findings from the phase III ASCEND-4 trial, in which ceritinib reduced the risk of disease progression or death by 45% compared with standard chemotherapy. The median progression-free survival (PFS) benefit favoring ceritinib was 8.5 months (HR, 0.55; 95% CI, 0.42-0.73; P <.001).”

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FDA Grants Brigatinib Priority Review for ALK-Positive NSCLC

Excerpt:

“The FDA has has granted a priority review to a new drug application (NDA) for brigatinib for patients with metastatic ALK-positive non–small cell lung cancer (NSCLC) who are resistant to prior crizotinib (Xalkori), according to a statement from the drug’s developer, Ariad Pharmaceuticals.

“The NDA, which follows a breakthrough therapy designation that was received in October 2014, is based on findings from the phase II ALTA trial. In results from the trial presented at the 2016 ASCO Annual Meeting, the confirmed objective response rate (ORR) for brigatinib at 180 mg daily was 54% and the median progression-free survival (PFS) was 12.9 months. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final decision on the NDA by April 29, 2017.”

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FDA Approves Atezolizumab for Lung Cancer

Excerpt:

“The FDA has approved atezolizumab (Tecentriq) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) who have progressed after a platinum-containing regimen and an FDA-approved targeted therapy for those patients harboring EGFR or ALK abnormalities.

“The approval is based on multiple clinical trials, the largest being the phase III OAK trial, which was presented at the 2016 ESMO Congress. In the study, atezolizumab reduced the risk of death by 26% compared with docetaxel in patients with advanced NSCLC following the failure of platinum-based chemotherapy. The median overall survival (OS) was improved by 4.2 months with the PD-L1 inhibitor versus chemotherapy. The survival benefit with atezolizumab was observed regardless of PD-L1 status or histology.”

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