This section highlights FDA-related milestones and regulatory updates for drugs developed by ADC Therapeutics (ADCT).
Over the past two years, ADC Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Claudin-6, ZYNLONTA, and ZYNLONTA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Claudin-6 - FDA Regulatory Timeline and Events
Claudin-6 is a drug developed by ADC Therapeutics for the following indication: In ovarian and NSCLC cancer models.
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:
- Claudin-6
- Announced Date:
- April 28, 2025
- Indication:
- In ovarian and NSCLC cancer models
Announcement
ADC Therapeutics SA announced data from preclinical studies of three exatecan-based antibody drug conjugates (ADCs) targeting Claudin-6 (CLDN6), prostate-specific membrane antigen (PSMA), and Alanine, Serine, Cysteine Transporter 2 (ACST2) as presented at the American Association for Cancer Research (AACR) Annual Meeting 2025.
AI Summary
ADC Therapeutics SA recently shared promising preclinical data at the AACR Annual Meeting 2025 on three novel exatecan‐based antibody drug conjugates (ADCs). One key candidate, ADCT-242, targets Claudin-6 (CLDN6) and showed strong, CLDN6-dependent antitumor activity in ovarian and non-small cell lung cancer models. The compound was well tolerated in both mice and cynomolgus monkeys even at high doses, underscoring its potential as a single agent or in combination therapies. Additional poster presentations detailed data on ADCs targeting prostate-specific membrane antigen (PSMA) and Alanine, Serine, Cysteine Transporter 2 (ACST2). These studies demonstrated that the PSMA-targeting ADC had significant antitumor effects in prostate cancer models, while the ASCT2-targeting ADC showed potent activity against both solid and hematologic cancer cell lines. Overall, these findings support further development of exatecan-based ADCs for a range of cancers.
Read Announcement- Drug:
- Claudin-6
- Announced Date:
- March 25, 2025
- Indication:
- In ovarian and NSCLC cancer models
Announcement
ADC Therapeutics SA announced abstracts detailing multiple preclinical programs have been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025, in Chicago, Illinois.
AI Summary
ADC Therapeutics SA announced that multiple preclinical abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025. The meeting is set to take place in Chicago, Illinois from April 25 to 30, 2025.
Among the highlights is an oral presentation on the preclinical investigation of ADCT-242, an exatecan-based antibody‐drug conjugate (ADC) targeting Claudin-6, designed for ovarian and non-small cell lung cancer models. This presentation, scheduled for Sunday, April 27, 2025, will explore the ADC's potential as a single agent or in combination with other therapies. In addition, poster presentations covering ADCs targeting PSMA and ASCT2 will discuss further advances in targeting various cancer types, reflecting the company’s commitment to addressing unmet needs in cancer treatment.
Read Announcement
ZYNLONTA - FDA Regulatory Timeline and Events
ZYNLONTA is a drug developed by ADC Therapeutics for the following indication: In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
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:
- ZYNLONTA
- Announced Date:
- June 16, 2025
- Indication:
- In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Announcement
ADC Therapeutics SA announced updated data from a Phase 2 multicenter investigator-initiated trial (IIT) of ZYNLONTA® to treat relapsed/refractory marginal zone lymphoma (r/r MZL) will be presented during a poster session at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20.
AI Summary
ADC Therapeutics SA announced updated results from a Phase 2 multicenter investigator-initiated trial evaluating ZYNLONTA® as a treatment for relapsed/refractory marginal zone lymphoma (r/r MZL). The study demonstrated an overall response rate of 85% and a complete response rate of 69%. Notably, 17 out of 18 patients who achieved a complete response maintained it, with the longest duration reaching 27 months from the start of treatment. The trial, led by Dr. Izidore S. Lossos at the Sylvester Comprehensive Cancer Center, involved 27 adult patients who had received at least one prior line of therapy and confirmed that ZYNLONTA is generally well tolerated with a manageable safety profile.
These updated findings will be presented during a poster session at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20, with data available online starting June 18.
Read Announcement- Drug:
- ZYNLONTA
- Announced Date:
- June 12, 2025
- Indication:
- In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Announcement
ADC Therapeutics SA announced updated data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) to be presented at the European Hematology Association 2025 Congress (EHA2025) in Milan, Italy.
AI Summary
ADC Therapeutics SA announced updated data from its LOTIS-7 Phase 1b open‐label trial, evaluating ZYNLONTA® combined with the bispecific antibody glofitamab (COLUMVI®) in patients with relapsed or refractory DLBCL. Early results are promising; among 30 efficacy‐evaluable patients, the overall response rate was 93.3% and the complete response rate reached 86.7%, with 25 of 26 patients who achieved a complete response still in remission at the data cut‐off. The data suggests that the combination offers meaningful clinical benefit and is generally well tolerated, with a manageable safety profile. In response to these encouraging outcomes, the study enrollment will expand to 100 patients at the 150 µg/kg dose. These findings will be presented at the European Hematology Association 2025 Congress in Milan, Italy, highlighting a potential new treatment option for hard‐to-treat lymphomas.
Read Announcement- Drug:
- ZYNLONTA
- Announced Date:
- March 27, 2025
- Indication:
- In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Announcement
ADC Therapeutics SA Provides Operational Update
AI Summary
ADC Therapeutics SA provided an operational update highlighting significant progress in its clinical trials for ZYNLONTA®. The company reported promising initial results from the LOTIS-7 Phase 1b trial, where the combination of ZYNLONTA® and glofitamab showed promising efficacy in patients with relapsed or refractory diffuse large B-cell lymphoma. Among the 18 efficacy-evaluable patients, a best overall response rate of 94% and a complete response rate of 72% were observed. The study’s dose expansion enrollment of 40 patients is expected to complete in the second quarter of 2025, with more mature data to follow later that year.
Additionally, ADC Therapeutics announced that full enrollment has been achieved for the LOTIS-5 Phase 3 confirmatory trial of ZYNLONTA® combined with rituximab, with updated data anticipated in late 2025. The company also noted a cash balance that should support its operations into the second half of 2026.
Read Announcement- Drug:
- ZYNLONTA
- Announced Date:
- December 11, 2024
- Indication:
- In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Announcement
ADC Therapeutics SA announced positive initial data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI™) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
AI Summary
ADC Therapeutics has announced encouraging initial results from the LOTIS-7 Phase 1b trial. The study evaluated the safety and efficacy of ZYNLONTA® when combined with the bispecific antibody glofitamab (COLUMVI™) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). The trial reported a remarkable best overall response rate of 94% and a complete response rate of 72% among the evaluable patients. These promising findings were consistent across two tested doses of ZYNLONTA® (120 µg/kg and 150 µg/kg).
The results also indicate a manageable safety profile. No dose-limiting toxicities were observed, and there were no instances of high-grade cytokine release syndrome or severe neurotoxicity. ADC Therapeutics is encouraged by these findings as they move forward with further enrollment and data collection, potentially paving the way for a best-in-class treatment option for r/r DLBCL patients.
Read Announcement- Drug:
- ZYNLONTA
- Announced Date:
- December 9, 2024
- Indication:
- In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Announcement
ADC Therapeutics SA announced updated data from the investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab to treat relapsed or refractory (r/r) follicular lymphoma (FL) were published in the December issue of The Lancet Haematology, following an oral presentation of the data at the recent 66th American Society of Hematology (ASH) Annual Meeting and Exposition.
AI Summary
ADC Therapeutics recently announced encouraging updated results from an investigator-initiated Phase 2 trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab for relapsed or refractory follicular lymphoma. The trial, which enrolled patients who had received at least one prior systemic therapy, showed a best overall response rate of approximately 97% and a complete response rate close to 77%. With a median follow-up of 15.6 months, the study reported a promising 12‐month progression-free survival rate of around 95%. These results highlight the potential of ZYNLONTA’s robust clinical activity, especially in high-risk patients and those with a high tumor burden. The findings were initially presented during an oral session at the 66th American Society of Hematology Annual Meeting and were later published in the December issue of The Lancet Haematology.
Read Announcement- Drug:
- ZYNLONTA
- Announced Date:
- December 6, 2024
- Indication:
- In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
Announcement
ADC Therapeutics SA announced that it will host a conference call and live webcast on Wednesday, December 11, 2024, at 8:30 a.m. EST to provide an update on preliminary data from the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and efficacy of ZYNLONTA® in combination with the bispecific antibody glofitamab (COLUMVI™) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
AI Summary
ADC Therapeutics SA announced a corporate update webcast scheduled for Wednesday, December 11, 2024, at 8:30 a.m. EST. During the webcast and conference call, the company will share preliminary data from the LOTIS-7 Phase 1b open‐label clinical trial. The trial is designed to evaluate the safety and efficacy of ZYNLONTA® when combined with the bispecific antibody glofitamab (COLUMVI™) for patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
This update is significant, as it may provide further insights into how the combination therapy might benefit patients who have not responded to previous treatments. Interested parties can register to join the call in advance or access the live webcast through the ADC Therapeutics website. The webcast will also be available as an archive for 30 days after the event.
Read Announcement
ZYNLONTA (loncastuximab tesirine-lpyl) - FDA Regulatory Timeline and Events
ZYNLONTA (loncastuximab tesirine-lpyl) is a drug developed by ADC Therapeutics for the following indication: Refractory Diffuse 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:
- ZYNLONTA (loncastuximab tesirine-lpyl)
- Announced Date:
- May 14, 2025
- Indication:
- Refractory Diffuse Large B-Cell Lymphoma
Announcement
ADC Therapeutics SA announced data presentations from the LOTIS-7 Phase 1b clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with glofitamab in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
AI Summary
ADC Therapeutics SA announced updated data from the LOTIS-7 Phase 1b clinical trial, which evaluated the combination of ZYNLONTA (loncastuximab tesirine-lpyl) and glofitamab for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The trial showed impressive early results among 22 evaluable patients, reporting an overall response rate (ORR) of 95.5% and a complete response (CR) rate of 90.9%. These findings suggest that the combination of two powerful anti-cancer agents could offer a promising new treatment option for patients with aggressive lymphoma.
Safety and tolerability data from the study were consistent with the known profiles of each agent. The updated data will be presented at the European Hematology Association 2025 Congress and at the 18th International Conference on Malignant Lymphoma, helping to further assess the potential for this new regimen in routine clinical practice.
Read Announcement- Drug:
- ZYNLONTA (loncastuximab tesirine-lpyl)
- Announced Date:
- December 30, 2024
- Indication:
- Refractory Diffuse Large B-Cell Lymphoma
Announcement
ADC Therapeutics SA announced the completion of enrollment in LOTIS-5, the Phase 3 confirmatory trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
AI Summary
ADC Therapeutics SA announced that enrollment is complete for LOTIS-5, its Phase 3 confirmatory trial evaluating the combination of ZYNLONTA® (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). This large-scale study is designed to confirm the benefit seen with ZYNLONTA and could support label expansion for second-line or later treatment options. The trial includes two parts; the first part, a non-randomized safety run-in, showed promising results, while the second part randomizes patients to receive either the Lonca-R combination or an alternative treatment regimen. The primary goal of LOTIS-5 is to evaluate progression-free survival, along with several secondary endpoints including overall survival and response rates. Topline results are expected by the end of 2025, with potential regulatory submission to the FDA planned for early 2026.
Read Announcement- Drug:
- ZYNLONTA (loncastuximab tesirine-lpyl)
- Announced Date:
- May 6, 2024
- Indication:
- Refractory Diffuse Large B-Cell Lymphoma
Announcement
ADC Therapeutics announced that initial data from an investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) demonstrated a high response rate in patients with relapsed/refractory (r/r) marginal zone lymphoma (MZL).
AI Summary
ADC Therapeutics announced promising initial results from a Phase 2 clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in patients with relapsed/refractory marginal zone lymphoma (MZL). In this investigator-initiated study, 15 evaluable patients were treated, and impressive outcomes have emerged. Researchers reported that 13 patients achieved a complete response, while one patient had a partial response. Importantly, all patients who responded to treatment maintained their response at the time of data cutoff on March 30, 2024.
The trial, conducted at the Sylvester Comprehensive Cancer Center at the University of Miami and City of Hope, also confirmed that ZYNLONTA was generally well-tolerated, with safety findings consistent with its known profile. These results highlight the potential of ZYNLONTA as an effective treatment option for patients with this rare and challenging form of non-Hodgkin lymphoma.
Read Announcement- Drug:
- ZYNLONTA (loncastuximab tesirine-lpyl)
- Announced Date:
- April 4, 2024
- Indication:
- Refractory Diffuse Large B-Cell Lymphoma
Announcement
ADC Therapeutics announced that Enrollment in Part 2 dose expansion has been initiated
AI Summary
ADC Therapeutics announced an important update from the LOTIS-7 trial, a Phase 1b study evaluating the combination of ZYNLONTA with bispecific antibodies in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. In the dose escalation (Part 1) of the trial, the treatment showed a promising safety profile with no dose-limiting toxicities, minimal to low-grade cytokine release syndrome, and no signs of immune effector cell-associated neurotoxicity syndrome. Encouraging early evidence of anti-tumor activity was observed among a range of lymphoma types. Based on these positive findings, ADC Therapeutics has now initiated enrollment in Part 2, which will further explore ZYNLONTA in combination with glofitamab at the 120 µg/kg and 150 µg/kg dose levels, specifically targeting second-line or later treatment in diffuse large B-cell lymphoma patients.
Read Announcement- Drug:
- ZYNLONTA (loncastuximab tesirine-lpyl)
- Announced Date:
- April 4, 2024
- Indication:
- Refractory Diffuse Large B-Cell Lymphoma
Announcement
ADC Therapeutics announced the completion of dose escalation in LOTIS-7, a Phase 1b open-label clinical trial evaluating ZYNLONTA® (loncastuximab tesirine-lpyl) in combination with bispecific antibodies glofitamab or mosunetuzumab in heavily pre-treated patients with relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL).
AI Summary
ADC Therapeutics has announced the completion of dose escalation in the LOTIS-7 Phase 1b trial evaluating ZYNLONTA® in combination with bispecific antibodies (glofitamab or mosunetuzumab) for patients with relapsed/refractory B-cell non-Hodgkin lymphoma. In this study, which involved heavily pre-treated patients, no dose-limiting toxicities were observed, and cases of cytokine release syndrome were either absent or low-grade. Notably, there were no instances of immune effector cell-associated neurotoxicity syndrome, suggesting a favorable safety profile for this combination treatment.
Early evidence of anti-tumor activity was observed among patients, and all three dose levels (90, 120, and 150 µg/kg) have been successfully expanded into Phase 2. This progress offers hope for broader treatment options in a patient population with significant unmet medical needs.
Read Announcement
