Europe OKs Brigatinib for ALK+NSCLC, Other Products

Zosia Chustecka

September 21, 2018

A new targeted agent for use in patients with nonsmall cell lung cancer (NSCLC) who test positive for anaplastic lymphoma kinase (ALK+) looks to be available soon in Europe. The Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for brigatinib (Alunbrig, Takeda) during its latest meeting. European Union marketing approval usually follows such a positive opinion in about 6 weeks.  

Brigatinib was approved for ALK+ NSCLC in the United States in April 2017.

NSCLC is the most common form of lung cancer, accounting for about 85% of all new cases. About 3% to 5% of patients with NSCLC test positive for the ALK gene rearrangement.

The drug is intended for use in patients who have already been treated with the first targeted agent available for this subgroup of patients, crizotinib (Xalkori, Pfizer), who have progressed or become intolerant to the drug. 

The data that led to the positive opinion for brigatinib come from the pivotal Phase 2 ALTA trial, conducted in patients with ALK+ NSCLC who had been previously treated with crizotinib.

In these patients, brigatinib demonstrated an objective response rate of 56% and an unprecedented median progression-free survival of 16.7 months and overall survival of 34.1 months, notes the manufacturer in a press release.

"The ALTA trial has established brigatinib as a potential second-line treatment option for ALK+ NSCLC by demonstrating significant efficacy with a manageable safety profile," said Jesús Gómez-Navarro, MD, vice president, head of Oncology Clinical Research and Development, Takeda. "With 16.7 months median progression-free survival, the longest of any ALK inhibitor to be reported in this setting, brigatinib offers great potential for patients who progressed on crizotinib," he notes.

Other Products  

A few other products for cancer patients were also given a positive opinion at the same CHMP meeting.

One of these was the orphan drug mogamulizumab (Poteligeo, Kyowa Kirin) for the treatment of mycosis fungoides or Sézary syndrome, the most common subsets of cutaneous T-cell lymphoma, a rare form of nonHodgkin’s lymphoma. The drug was recently approved in the United States.

Another was a new generic version of paclitaxel (Apealea, Oasmia Pharmaceutical) for use with carboplatin in the treatment of ovarian cancer.

The CHMP also gave a positive opinion for three new biosimilars of pegfilgrastim, the colony-stimulating factor used for neutropenia that develops with chemotherapy. The new products are Fulphila (Mylan), Pelmeg (Cinfa Biotech), and Ziextenzo (Sandoz). 

Two other biosimilar pegfilgrastim products — Pelgraz (Accord Healthcare) and Udenyca (ERA Consulting) — were granted a positive opinion in July 2018.

One of these biosimilars, Fulphila, was approved by the US Food and Drug Administration in June 2018.

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