AstraZeneca Scores Japanese Approvals in NSCLC, gMG and Breast Cancer

AstraZeneca_Bodo Marks/picture alliance via Getty

Courtesy of Bodo Marks/Picture Alliance via Getty Images

AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, based on positive results from three global trials for non-small cell lung cancer, myasthenia gravis and early breast cancer, respectively.

The nods came from the Japanese Ministry of Health, Labor and Welfare (MHLW).

Tagrisso Obtains Approval for EGFRm NSCLC after Surgery

The global ADAURA Phase III trial evaluated Tagrisso (osimertinib) for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) NSCLC post-surgery. The drug demonstrated significant improvement in disease-free survival among patients with Stage II and IIIA EGFRm NSCLC and in the overall population of participants with Stage IB-IIIA disease.

Further study will investigate overall survival as well, the researchers stated. Details are published in The New England Journal of Medicine.

Lung cancer is the leading cause of cancer death among patients with NSCLC in Japan, with over 35 percent developing tumors with an EGFR mutation.

"Patients diagnosed with lung cancer in Japan are more likely than patients anywhere else in the world to be alive five years after their diagnosis. Yet lung cancer remains the country’s leading cause of cancer death," Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said in a statement.

Tagrisso is already approved for early-stage lung cancer in over 85 countries. This marks its third approved indication in Japan, following approvals for second-line T790M in 2016 and first-line EGFRm NSCLC in 2018. The latest approval makes targeted treatment options available for patients after undergoing surgery.

Ultomiris Scores Approval for Generalized Myasthenia Gravis

The MHLW approved Ultomiris (ravulizumab), making it the first and only approved long-acting C5 complement inhibitor to reduce the treatment burden for adults with generalized myasthenia gravis (gMG).

Eligible patients are those whose disease is anti-acetylcholine antibody-positive and suffer from symptoms that even high-dose IV immunoglobulin therapy or plasmapheresis cannot manage. Ultomiris is also approved for patients who are not eligible for high-dose IVIg or plasmapheresis due to complications, adverse reactions and other factors.

Generalized myasthenia gravis is a rare autoimmune neuromuscular disorder that affects around 22,000 people in Japan. It is characterized by severe muscle weakness and loss of muscle function.

The regulator's decision is based on the successful CHAMPION-MG Phase III trial, which demonstrated Ultomiris' ability to significantly improve conditions for people with gMG. Participants were evaluated using the Myasthenia Gravis-Activities of Daily Living Profile at week 26, while prolonged follow-up results were taken from an extension study that lasted 60 weeks.

Full results are published in NEJM Evidence. In the United States, Ultomiris is approved for adults with anti-AChR antibody-positive gMG. Regulatory evaluations are ongoing in other countries as well.

Lynparza Approved for Early Breast Cancer

Lynparza (olaparib), the first-in-class PARP inhibitor that AstraZeneca developed with MSD, garnered the Japanese government's nod to be the first and only approved medicine for patients with BRCA-mutated, HER2-negative early breast cancer.

The decision was based on positive outcomes from the OlympiA Phase III trial, which tested the drug's performance in terms of invasive disease-free survival, overall survival, safety and tolerability versus a placebo. Complete results are published in NEJM.

There are around 95,000 people expected to be diagnosed with breast cancer in Japan in this year alone, and more than 15,000 are likely to die from the illness. Of the 80 percent of patients with HER2-negative breast cancer, 11 percent have BRCA mutations.

"Today’s approval marks a significant leap forward for breast cancer patients in Japan, where it is the most commonly diagnosed cancer among women,"  Frederickson said in a statement. "Patients with BRCA mutations have high rates of disease recurrence and lower survival, and Lynparza has been shown to significantly reduce both the risk of recurrence and death."

Lynparza was approved in the U.S. in March for germline BRCAm, HER2-negative high-risk early breast cancer. It was approved in the E.U. in August for the same indication. 

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