This section highlights FDA-related milestones and regulatory updates for drugs developed by Lyell Immunopharma (LYEL).
Over the past two years, Lyell Immunopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYL314, LYL273, IMPT-314, and LYL797. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LYL314 FDA Regulatory Timeline and Events
LYL314 is a drug developed by Lyell Immunopharma for the following indication: For the Treatment of Aggressive Large B-cell Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYL314
- Announced Date:
- February 12, 2026
- Indication:
- For the Treatment of Aggressive Large B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc announced that the first patient has been dosed in the PiNACLE – H2H Phase 3 trial evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the second-line (2L) setting.
AI Summary
Lyell Immunopharma announced the first patient has been dosed in the PiNACLE – H2H Phase 3 trial (NCT07188558), a head‑to‑head study evaluating rondecabtagene autoleucel (ronde‑cel, LYL314) versus lisocabtagene maraleucel (liso‑cel) or axicabtagene ciloleucel (axi‑cel) for patients with relapsed or refractory large B‑cell lymphoma receiving second‑line therapy. The trial will compare safety and efficacy outcomes to determine whether ronde‑cel offers improved results in this 2L setting.
Ronde‑cel is a next‑generation CAR T therapy that targets both CD19 and CD20 with an “OR” logic so it can attack B cells expressing either antigen. It is manufactured to enrich for CD62L‑expressing cells, increasing proportions of naïve and central memory T cells. Lyell says this design aims to raise complete response rates and extend the duration of responses compared to approved CD19‑targeted CAR T therapies. More details are available on clinicaltrials.gov (NCT07188558).
Read Announcement- Drug:
- LYL314
- Announced Date:
- December 7, 2025
- Indication:
- For the Treatment of Aggressive Large B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc announced new clinical and translational data from the ongoing clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) in patients with large B-cell lymphoma (LBCL), which were presented today in two oral presentations at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.
AI Summary
Lyell Immunopharma reported new clinical and translational data for rondecabtagene autoleucel (ronde-cel) presented in two oral talks at the 67th ASH meeting. In the 3L+ relapsed/refractory large B‑cell lymphoma group, ronde-cel showed a 93% overall response rate, 76% complete response rate, and median progression‑free survival of 18 months. In a mostly primary‑refractory 2L cohort, responses were 83% overall and 61% complete, with 70% of complete responders remaining in remission at six months or longer. Across 69 treated patients, safety was manageable for outpatient use: no Grade ≥3 cytokine release syndrome and, with dexamethasone prophylaxis, ≤5% experienced Grade ≥3 ICANS; neurologic events resolved in a median of four days.
Translational studies showed ronde-cel is enriched for CD62L‑positive T cells, producing more naïve/central memory cells and up to three‑fold greater expansion after infusion versus published CD19 CAR T data. Cells retained the ability to proliferate, kill tumor cells, and secrete cytokines one to two months after infusion. The results were presented by Sarah M. Larson, MD, and Akil Merchant, MD.
Read Announcement- Drug:
- LYL314
- Announced Date:
- September 3, 2025
- Indication:
- For the Treatment of Aggressive Large B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial and the formation of a Steering Committee of preeminent lymphoma experts.
AI Summary
Lyell Immunopharma has launched PiNACLE-H2H, the first Phase 3 head-to-head CAR T-cell therapy trial in second-line large B-cell lymphoma. About 400 patients will be randomly assigned to receive either rondecabtagene autoleucel (ronde-cel) or the investigator’s choice of approved CD19 CAR T therapies (liso-cel or axi-cel). The trial’s main goal is to compare event-free survival between the two treatment groups, with enrollment expected to begin in early 2026.
Ronde-cel is Lyell’s next-generation, dual-targeting CD19/CD20 CAR T-cell product designed to improve complete response rates and durability. By targeting B cells that express CD19, CD20, or both, ronde-cel aims to overcome resistance seen with single-antigen therapies. Its manufacturing process enriches for naïve and central memory T cells to boost long-term antitumor activity.
To guide this landmark study, Lyell formed a Steering Committee of leading lymphoma experts from top cancer centers. These specialists will advise on trial design, patient selection, safety monitoring, and data analysis to ensure robust, clinically meaningful results.
Read Announcement- Drug:
- LYL314
- Announced Date:
- June 17, 2025
- Indication:
- For the Treatment of Aggressive Large B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc. announced positive new clinical data from the multi-center Phase 1/2 trial of LYL314, including data from patients with large B-cell lymphoma (LBCL) treated in the third- or later-line (3L+) setting.
AI Summary
Lyell Immunopharma recently shared promising new clinical data from their multi-center Phase 1/2 trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting. In this group, LYL314 achieved an overall response rate of 88% and a complete response rate of 72%. Notably, 71% of those who reached complete response maintained it for at least six months, indicating durable results. The treatment demonstrated a manageable safety profile suitable for outpatient care, with no instances of severe cytokine release syndrome and low rates of neurotoxicity that resolved quickly.
The company is moving forward with a pivotal single-arm PiNACLE trial in CAR T-naïve patients, and these positive findings underline LYL314’s potential to offer significant benefits for patients with relapsed or refractory large B-cell lymphoma.
Read Announcement
LYL273 FDA Regulatory Events
LYL273 is a drug developed by Lyell Immunopharma for the following indication: Metastatic Colorectal Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYL273
- Announced Date:
- November 10, 2025
- Indication:
- Metastatic Colorectal Cancer
Announcement
Lyell Immunopharma, Inc. announced it has strengthened its solid tumor pipeline by acquiring global rights to LYL273 (formerly GCC19CART), a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers, from Innovative Cellular Therapeutics (ICT).
AI Summary
Lyell Immunopharma announced it has acquired global rights (outside mainland China, Hong Kong, Macau and Taiwan) to LYL273 from Innovative Cellular Therapeutics. LYL273 is an autologous CAR T‑cell therapy that targets guanylyl cyclase-C (GCC) and is enhanced with CD19 CAR expression and controlled cytokine release to boost T‑cell expansion, tumor infiltration and cancer cell killing in solid tumors such as metastatic colorectal cancer (mCRC).
In a U.S. Phase 1 trial, LYL273 showed strong activity: at the highest dose tested the overall response rate was 67% and disease control rate 83%, with a median progression‑free survival of 7.8 months at that dose. Common side effects included cytokine release syndrome and diarrhea, mostly low‑to‑moderate grade; immune neurotoxicity occurred and resolved with treatment. One patient experienced a dose‑limiting toxicity and later died from fungal sepsis.
Under the deal Lyell paid $40 million up front plus 1.9 million shares and may pay additional clinical, regulatory and commercial milestones and royalties. Lyell expects funding into 2027 to advance LYL273 and other programs.
Read Announcement
IMPT-314 FDA Regulatory Events
IMPT-314 is a drug developed by Lyell Immunopharma for the following indication: For the treatment of B-cell Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMPT-314
- Announced Date:
- May 1, 2025
- Indication:
- For the treatment of B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc. announced that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025.
AI Summary
Lyell Immunopharma, Inc. announced that new clinical data from its Phase 1/2 trial of LYL314 in large B-cell lymphoma will be presented as an oral session at the International Conference on Malignant Lymphoma (ICML) 2025. The presentation is scheduled for June 18, 2025, at ICML in Lugano, Switzerland. LYL314 is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to treat aggressive large B-cell lymphoma, especially in patients who have not responded well to previous treatments.
This new clinical data emphasizes LYL314's potential to produce high rates of durable complete responses in patients with relapsed or refractory large B-cell lymphoma. The findings could offer valuable insights into advancing next-generation CAR T-cell therapies and improving treatment options for patients battling this aggressive form of cancer.
Read Announcement- Drug:
- IMPT-314
- Announced Date:
- December 9, 2024
- Indication:
- For the treatment of B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc. announced initial positive clinical data from the multi-center Phase 1-2 study of IMPT-314 in patients with large B-cell lymphoma that is being presented at the 66th American Society of Hematology (ASH) Annual Meeting.
AI Summary
Lyell Immunopharma, Inc. has revealed initial positive data from its multi-center Phase 1-2 trial of IMPT-314 in patients with large B-cell lymphoma. The study, presented at the 66th American Society of Hematology Annual Meeting, focused on heavily pretreated, CAR T-cell naïve patients. IMPT-314 is a dual-targeting CAR T-cell therapy designed to target both CD19 and CD20, and early results show a 94% objective response rate and a 71% complete response rate by three months.
The safety profile of IMPT-314 was favorable, with no high-grade cytokine release syndrome reported and only a small percentage experiencing Grade 3 immune effector cell-associated neurotoxicity. Additionally, the treatment demonstrated robust cell expansion and maintained a high proportion of naïve and central memory T cells, which may contribute to durable clinical responses in these patients.
Read Announcement
LYL797 FDA Regulatory Events
LYL797 is a drug developed by Lyell Immunopharma for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYL797
- Announced Date:
- June 26, 2024
- Indication:
- Solid tumors
Announcement
Lyell Immunopharma, Inc announced initial clinical and translational data from its Phase 1 trial of LYL797, its first-generation reprogrammed ROR1 CAR T‑cell product candidate enhanced with proprietary anti-exhaustion technology.
AI Summary
Lyell Immunopharma announced promising initial clinical and translational data from its Phase 1 trial of LYL797, a first-generation reprogrammed ROR1 CAR T‑cell product enhanced with proprietary anti‑exhaustion technology. In patients with relapsed/refractory triple‑negative breast cancer, the trial showed a dose‑dependent antitumor response, with a 40% objective response rate and a 60% clinical benefit rate at the highest dose of 150 x 10⁶ CAR T cells. The data revealed that LYL797 not only expanded effectively but also infiltrated solid tumors to kill cancer cells. Importantly, the treatment was generally safe in patients without lung involvement, while pneumonitis was noted in those with lung metastases, which is being managed with steroids. These results underscore the potential of anti‑exhaustion technologies to improve CAR T‑cell therapy outcomes and support further exploration in other ROR1‑positive solid tumors.
Read Announcement
