J&J Gains FDA Approval for Faster-Acting Lung Cancer Therapy
The new subcutaneous version of Rybrevant, for use in a first-line combination therapy, significantly cuts administration time for patients with a common form of lung cancer.
Johnson & Johnson (NYSE: JNJ) has secured U.S. Food and Drug Administration (FDA) approval for Rybrevant Faspro, a new, subcutaneously administered version of its therapy for a common type of non-small cell lung cancer (NSCLC). Shares of the healthcare giant traded modestly higher on the news, rising approximately 0.5% to $210.33 in morning trading.
The approval clears the treatment for first-line use in combination with the oral therapy lazertinib for patients with locally advanced or metastatic NSCLC whose tumors have specific genetic mutations known as epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution.
This new formulation represents a significant improvement in convenience for patients. The original version of Rybrevant is administered intravenously, a process that can take hours. According to a company announcement, Rybrevant Faspro is an under-the-skin injection that can be given in about five minutes, drastically reducing the time patients must spend in a clinical setting.
This approval fortifies Johnson & Johnson's position in the highly competitive oncology market, particularly in the lucrative field of targeted lung cancer therapies. For the healthcare conglomerate, which has a market capitalization of approximately $516 billion, expanding its cancer treatment portfolio with more convenient and effective options is a key strategic priority.
The approval is based on clinical data from the PAPILLON study, which demonstrated the efficacy and safety of the Rybrevant and lazertinib combination. While the convenience of the subcutaneous formulation is the primary feature of this specific approval, the underlying combination therapy has shown promise in improving outcomes for patients with EGFR-mutated NSCLC, a prevalent form of the disease.
Johnson & Johnson's stock has been performing strongly, trading near its 52-week high of $215.19. This latest regulatory win is expected to bolster investor confidence in the company's pharmaceutical pipeline and its ability to continue delivering growth through innovation in its core healthcare segments.