RARITAN, N.J. - The U.S. Food and Drug Administration (FDA) has approved a new first-line treatment for patients with a specific type of lung cancer, Johnson & Johnson announced Today. The treatment, RYBREVANT® (amivantamab-vmjw) combined with LAZCLUZE™ (lazertinib), is indicated for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with certain epidermal growth factor receptor (EGFR) mutations.
This marks the first approval of a multitargeted, chemotherapy-free regimen for this patient population, demonstrating a 30 percent reduction in the risk of disease progression or death when compared to the previous standard of care, osimertinib. The median progression-free survival (PFS) for patients treated with the new combination was 23.7 months, versus 16.6 months for osimertinib, with a median duration of response extending nine months longer.
The decision by the FDA is based on the results from the Phase 3 MARIPOSA study, which provided evidence of the treatment's efficacy and safety. The combination targets EGFR mutations directly and is designed to engage the immune system in the fight against cancer cells. Lung cancer remains the leading cause of cancer mortality globally, with NSCLC accounting for the majority of cases.
Jill Feldman, a lung cancer survivor and co-founder of the EGFR Resisters patient advocacy group, expressed optimism about the new treatment option, highlighting the unmet needs of patients with EGFR-mutated NSCLC. Dr. Alexander Spira, a study investigator, also emphasized the significance of the new regimen, which aims to provide better outcomes while reserving chemotherapy for later stages of treatment.
The safety profile of the RYBREVANT® and LAZCLUZE™ combination was consistent with that of the individual treatments, with venous thromboembolic events observed in some patients.
Further information on the MARIPOSA study and other ongoing clinical trials involving RYBREVANT® can be found at RYBREVANT.com. Access to the treatment will be supported by J&J's patient support program, J&J withMe.
This announcement is based on a press release statement and contains no endorsements or subjective language.
In other recent news, Johnson & Johnson (J&J) has secured significant claimant support for its proposed $6.48 billion settlement related to allegations that its talc products caused cancer. The healthcare conglomerate is set to announce that at least 75% of claimants have voted in favor of a bankruptcy settlement, meeting the legal threshold necessary for a judge to approve the settlement. This development comes as J&J also received FDA approval for a chemotherapy-free combination therapy for patients with a specific type of non-small cell lung cancer, marking a significant step forward in cancer treatment.
In parallel, the Biden administration has selected 10 prescription medicines for price negotiations with the Medicare health program. Notably, J&J's blood thinner, Xarelto, is among these drugs, which have been identified as some of the most costly for Medicare. As a result of these negotiations, the U.S. government is set to save $6 billion in the first year from newly negotiated lower prices on these leading prescription drugs for Medicare.
These are the recent developments for J&J, a company that continues to make headlines in the healthcare sector. The company's strategic moves and regulatory approvals underscore its ongoing efforts to address both its legal challenges and its commitment to advancing medical treatments.
InvestingPro Insights
In light of the FDA's approval of Johnson & Johnson's new lung cancer treatment, investors may find the company's financial health and market performance of particular interest. Johnson & Johnson, a prominent player in the pharmaceuticals industry, has been demonstrating financial resilience with a market capitalization of $384.27 billion. The company's commitment to shareholder returns is evident, as it has maintained dividend payments for 54 consecutive years, with a current dividend yield of 3.11%.
From an investment standpoint, Johnson & Johnson is trading at a low P/E ratio relative to near-term earnings growth, standing at 20.2 based on the last twelve months as of Q2 2024. This could suggest that the stock is undervalued in relation to its earnings potential. Moreover, the company's stock generally trades with low price volatility, adding a layer of stability for investors. It is also worth noting that Johnson & Johnson's cash flows can sufficiently cover interest payments, indicating a healthy financial position for the company.
For readers interested in more in-depth analysis, there are additional InvestingPro Tips available for Johnson & Johnson, which can be found at Investing.com/pro/JNJ. These tips provide further insights into the company's financial metrics and stock performance, helping investors make more informed decisions.
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