February 23, 2020，Chugai, a Japanese pharmaceutical company controlled by Roche, recently announced that the Ministry of Health, Labor and Welfare (MHLW) has approved the targeted anticancer drug Alecensa（alectinib）150mg capsules a new indication for the treatment of relapsed or refractory ALK fusion gene positive anaplastic large cell lymphoma (ALK + ALCL). Previously, MHLW had granted Alecensa the orphan drug qualification for this indication.

The common treatment for ALCL is chemotherapy. However, for patients with ALCL who relapse after chemotherapy, there is no standard treatment, so the demand for new effective drugs is increasing. The approval of Alecensa's new indication will provide a new and important treatment option for patients with relapsed or refractory ALK + ALCL.

This approval is based on data from the ALC-ALCL study. This is a multi-center phase II study started in 2015 to evaluate the efficacy and safety of Alecensa in patients with relapsed or refractory ALK + ALCL. A total of 10 patients were enrolled in the study. The results showed that the overall remission rate (ORR) of Alecensa treatment was 80.0% (bilateral 90% CI: 56.15-95.91%). The incidence of adverse reactions was 100%. The most common adverse reactions included: maculopapular rash (40.0%, 4/10 cases), and upper respiratory tract infections, bronchitis, and increased blood alkaline phosphatase (30.0% each, 3/10 cases) ).

ALCL is a non-Hodgkin's lymphoma that originates from T cells in lymphocytes. It is one of the four subtypes of peripheral T cell lymphoma and belongs to malignant lymphoma. The degree of malignancy is classified as "moderate", and the disease progression needs to be observed monthly. In Japan, the proportion of ALCL in malignant lymphoma is 1.5% -2.0%, about half of which are reported as ALK positive. Considering the data from a global study, the 5-year survival rate of successful ALK + ALCL patients receiving chemotherapy is 60%, so relapsed and refractory cases are estimated to account for 40%.

Alecensa is a new small molecule tyrosine kinase inhibitor (TKI) that targets ALK, can cross the blood-brain barrier, and has strong efficacy against brain metastases. The drug has been approved: (1) Single-agent second-line treatment Patients with ALK-positive NSCLC who have received Xalkori (crizotinib) progression in the past; (2) single-agent first-line treatment of ALK-positive NSCLC patients; (3) single-agent treatment of patients with relapsed or refractory ALK-positive ALCL

It is worth mentioning that, in the National Comprehensive Cancer Network (NCCN) guidelines, in the treatment of ALK-positive metastatic NSCLC, Alecensa is the only first-line treatment plan (preferred) (Class 1).

In China, Alecensa was approved in August 2018 as a monotherapy for the treatment of patients with ALK-positive NSCLC. Lung cancer is the most common type of cancer and the leading cause of cancer death. NSCLC is the most common type of lung cancer, and ALK-positive NSCLC is a unique type, commonly seen in younger (median age 52 years) lung cancer populations with no history of smoking, especially in a specific type of NSCLC population called adenocarcinoma，approximately 5% of NSCLC are ALK positive.

Source of the original text: Chugai Obtains approval for Additional Indication of Alecensa for Recurrent or Refractory ALK Fusion Gene-Positive Anaplastic Large Cell Lymphoma

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