J&J drug combo for lung cancer approved by FDA

Dive Brief:

• The Food and Drug Administration has approved a new combination drug regimen from Johnson & Johnson to treat a common type of advanced lung cancer with certain genetic mutations.
• J&J’s Rybrevant is now cleared for use with another drug called Lazcluze in people with previously untreated non-small cell lung cancer that’s metastasized or advanced locally. Only people with specific mutations in a gene known as EGFR are eligible for treatment.
• The approval is based on results from a study that compared the combination to AstraZeneca’s lung cancer drug Tagrisso. In a statement, J&J described the new treatment as the first chemotherapy-free regimen that’s demonstrated superiority to Tagrisso in this setting.

Dive Insight:

Approval of Rybrevant and Lazcluze introduces a new competitor to Tagrisso, widespread use of which in EGFR-mutated lung cancer has made it AstraZeneca’s second highest-selling product.

For this reason, analysts closely watched MARIPOSA, the J&J study that compared the two regimens. Data, which was first released last September and published in June, showed J&J’s combination reduced the risk of cancer progression or death by 30% compared to Tagrisso alone. Results from the June paper also suggested a lower relative risk of death.

However, about 10% of patients given Rybrevant and Lazcluze discontinued treatment due to side effects, compared to 3% of those on Tagrisso. Investigators also reported a safety signal of venous thromboembolic events. As a result, the FDA is requiring patients receive prophylactic anticoagulation during the first months of therapy with J&J’s regimen.

Competitively, the relevant comparator treatment may also have shifted since J&J ran its study. Testing by AstraZeneca has now shown that combining Tagrisso with chemotherapy can improve progression-free survival over Tagrisso alone.

Non-small cell lung cancer, or NSCLC, is the most common form of the tumor type. Frequently, these tumors are driven to growth by mutations in the EGFR gene. Rybrevant and Lazcluze are approved to treat NSCLC tumors that test positive for certain mutations where pieces of genetic code have been deleted or substituted.

Rybrevant, which was first approved in 2021, is a bispecific antibody that binds to two different types of proteins. Lazcluze is an oral drug aimed at EGFR, and works by inhibiting a kind of enzyme that, among other functions, plays a role in the transformation of normal cells to cancerous ones.

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