FOIAengine: Questions Seek Adverse Reports about Carvykti
According to a new PoliScio Analytics analysis of early 2025 Freedom of Information Act requests, investment firm Point72 has launched a significant FOIA-driven investigation into Johnson & Johnson’s popular cancer drug Carvykti.
According to Johnson & Johnson’s SEC filings and press releases, Carvykti has contributed significantly to the company’s recent financial performance and has benefitted hundreds of multiple myeloma patients. However, since the drug’s approval in 2022, the Food and Drug Administration’s adverse event reports attribute 159 deaths and 1,112 other serious cases to use of the drug.
Hedge fund Point72, a leading alternative investment firm employing long/short equity and quantitative strategies, is seeking additional detail about those adverse event reports. During February and March, the firm submitted to the FDA 22 nearly identical FOIA requests seeking “detailed case reports, source documents, and MedWatch forms” for 217 separate Carvykti adverse event reports issued by the FDA from 2022 through the end of 2024. The Point72 requests list each report case number it is seeking. Because only the case IDs differ in each request, Point72 may have submitted 22 separate requests to avoid overwhelming the FDA with one massive request.
These requests can be found in PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows. Updates to the FOIAengine database are ongoing.
The filing of FOIA requests for FDA adverse event reports is a well-known approach used by investors, law firms, companies, and other researchers to gain detailed information about a drug’s real-world impacts. The first step in preparing such a FOIA request is to query the FDA’s public, online Adverse Event Reporting System (FAERS) that enables anyone to find short summaries of drug-caused adverse events. But FAERS takes researchers only so far. To review the FDA’s detailed case reports and source documents describing the adverse events, one must submit to the FDA a FOIA request identifying the specific case number.
Carvykti was approved by the FDA in 2022 as a treatment used for adult patients who have cancer of the bone marrow called multiple myeloma. It is used when at least one other treatment has not worked or has stopped working. It is made from a patient’s own white blood cells, which have been genetically modified to recognize and attack the patient’s multiple myeloma cells.
Its development and commercialization was the result of an exclusive worldwide license and collaboration agreement between the Janssen Pharmaceutical Companies of Johnson & Johnson and Legend Biotech USA, Inc., which manufactures the product
Carvykti has shown promise in extending the lives of those suffering from multiple myeloma. In September of last year Johnson & Johnson announced the results of a long-term study showing that a single infusion of Carvykti reduced the risk of death by 45 percent versus standard therapies.
And Carvykti has helped Johnson & Johnson’s bottom line as well. At the end of 2024, the company announced that its Innovative Medicine group’s worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.5%, driven by Carvykti and several other drugs.
Notwithstanding its medical and financial success, questions persist about the risks posed by the drug. Carvykti is one of six similar FDA-approved drugs known as “CAR-T treatments,” which were approved after a 15-year observational study to assess the potential for long-term adverse health outcomes and secondary malignancies that could occur after treatment. The other CAR-T treatments are Abecma, Breyanzi, Kymriah, Tecartus, and Yescarta.
Because of the possible risks, manufacturers are required to warn users of many potential side effects, including altered mental state, confusion, infections, nausea, decreased appetite, fast or irregular heartbeat, and an increase in the risk of certain fatal conditions, such as COVID-19, certain blood cancers, and HIV.
In December 2023, the FDA mandated a black box warning for Carvykti highlighting an increased risk of secondary cancers, including myelodysplastic syndrome and acute myeloid leukemia. This decision was based on clinical studies and post-marketing surveillance indicating a more than 10 percent increased risk of blood cancers associated with the therapy. Of the 10 patients in the study experiencing bone marrow problems, nine eventually died.
In late November, the FDA launched an ongoing investigation into these secondary cancer risks. The FDA now recommends that patients or clinical trial participants receiving these treatments be monitored by a health care professional for the rest of their lives for new cancers that may develop.
The addition of the black box warning and the observed early deaths from Carvykti have led to increased scrutiny from regulatory bodies, the medical community, law firms, and now Point72. The hedge fund’s significant data requests indicate that the investment firm may be analyzing Carvykti’s financial prospects.
This isn’t the first time FOIA requests have targeted Carvykti. According to FOIAengine, 11 similar requests for Carvykti adverse event reports were filed between 2022 and 2024.
- The law firm of Kelley Drye and Warren on January 25 and 26, 2024.
- Point72, previously on January 2, 2024.
- Taylor Research Group on December 5, 2023.
- Sung Chun Kim, Esq. on June 1, 2022, and December 1, 2023.
- RTW – Lauren Lee on November 29, 2023.
- FOIA Professional Services on August 3, 2022.
- FOI Services, Inc. on April 4, 2022.
- Adaptimmune, LLC on March 23, 2022.
- Favus Institutional Research on March 2, 2022.
FOIAengine access now is available for all professional members of Investigative Reporters and Editors, a non-profit organization dedicated to improving the quality of journalism. IRE is the world’s oldest and largest association of investigative journalists. Following the federal government’s shutdown of FOIAonline.gov last year, FOIAengine is the only source for the most comprehensive, fully searchable archive of FOIA requests across dozens of federal departments and agencies. FOIAengine has more robust functionality and searching capabilities and standardizes data from different agencies to make it easier to work with. PoliScio Analytics is proud to be partnering with IRE to provide this valuable content to investigative reporters worldwide.
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Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Learn more about FOIAengine here. Sign up here to become a trial user of FOIAengine.
Write to Randy E. Miller at randy@poliscio.com.
