EMA committee recommends repotrectinib for lung cancer

PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY) has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of repotrectinib for the treatment of adult patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) and for certain adult and pediatric patients with advanced solid tumors. This recommendation is now under review by the European Commission, with a final decision expected in January 2025.

The CHMP's positive opinion of repotrectinib, a next-generation tyrosine kinase inhibitor, is based on the outcomes of the TRIDENT-1 and CARE clinical trials. These studies showed that repotrectinib led to clinically meaningful response rates and durable activity in patients, including intracranial responses and in those with common resistance mutations. The safety profile was described as generally manageable with routine care.

Repotrectinib has been previously approved in the United States for similar indications, with the U.S. Food and Drug Administration granting the medication to adult patients with advanced ROS1-positive NSCLC in November 2023, and for patients with NTRK-positive solid tumors in June 2024.

The TRIDENT-1 trial is an ongoing global Phase 1/2 study evaluating repotrectinib in advanced solid tumors, including NSCLC with ROS1 and NTRK fusions. The CARE trial focuses on pediatric and young adult patients with advanced solid tumors harboring ALK, ROS1, or NTRK1-3 gene alterations. Both trials aim to further assess long-term outcomes and additional endpoints.

Lung cancer, particularly NSCLC, represents a significant portion of cancer diagnoses and is often aggressive, with a subset of patients exhibiting ROS1 fusions. Similarly, NTRK gene fusions in solid tumors are rare but can lead to aggressive cancer growth, making targeted therapies like repotrectinib potentially valuable in treatment regimens.

The recommendation by CHMP marks a step towards addressing the need for new treatments in the EU for these patient populations. Bristol Myers Squibb has expressed gratitude to the patients and investigators involved in the trials and looks forward to the possibility of providing this treatment option in the EU.

This article is based on a press release statement from Bristol Myers Squibb.

In other recent news, Bristol-Myers Squibb (NYSE:) has been the subject of numerous analyst upgrades and adjustments. BMO Capital increased its stock price target from $57.00 to $61.00, maintaining an Outperform rating, due to the promising position of Bristol-Myers' drug, Cobenfy, in the market. Leerink Partners also raised its target for Bristol-Myers Squibb from $55 to $73, citing optimism for Cobenfy and milvexian, a novel blood thinner. The company's third-quarter earnings saw a 20% increase in growth portfolio revenues, a key factor in these upgrades.

Bristol-Myers Squibb has also been making significant strides in clinical trials. Notably, the FDA approved Cobenfy, a new treatment for schizophrenia, and the company reported promising news about milvexian. Furthermore, Bristol-Myers Squibb's Phase 3 EMERGENT-4 and EMERGENT-5 trials showed sustained improvements in schizophrenia symptoms over a 52-week period with Cobenfy treatment.

In addition to these financial and clinical highlights, Bristol-Myers Squibb recently acquired Karuna Therapeutics (NASDAQ:), aiming to enhance long-term growth with ongoing trials in schizophrenia and Alzheimer's. The company also plans to initiate three Phase 3 studies in 2024 and present Phase 1 data for CD19 NEX-T cell therapy. These recent developments underscore Bristol-Myers Squibb's commitment to growth and innovation.

InvestingPro Insights

As Bristol Myers Squibb (NYSE: BMY) awaits the European Commission's decision on repotrectinib, investors may find additional context in the company's financial metrics and market performance. According to InvestingPro data, BMY boasts a substantial market capitalization of $118.65 billion, underlining its significant presence in the pharmaceutical industry.

The company's revenue for the last twelve months as of Q3 2024 stood at $47.44 billion, with a notable revenue growth of 5.56% over the same period. This growth aligns with BMY's ongoing efforts to expand its product portfolio, including potential new treatments like repotrectinib.

InvestingPro Tips highlight that BMY has maintained dividend payments for 54 consecutive years, demonstrating a commitment to shareholder returns. The current dividend yield is 4.1%, which may be attractive to income-focused investors. Additionally, the stock has shown strong performance recently, with a 20.45% price total return over the last three months.

It's worth noting that 13 analysts have revised their earnings downwards for the upcoming period, which investors should consider alongside the positive news about repotrectinib. This could reflect broader market challenges or specific company factors that may impact short-term financial performance.

For a more comprehensive analysis, InvestingPro offers 14 additional tips for BMY, providing deeper insights into the company's financial health and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.