FDA Events for Sutro Biopharma (STRO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Sutro Biopharma (STRO).
Over the past two years, Sutro Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
luvelta. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
luvelta - FDA Regulatory Timeline and Events
luvelta is a drug developed by Sutro Biopharma for the following indication: Treatment of endometrial 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:
- luvelta
- Announced Date:
- March 15, 2025
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer®.
AI Summary
Sutro Biopharma, Inc. presented expanded data from the dose-optimization portion of the REFRαME-O1 trial at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer. The trial focused on luveltamab tazevibulin (luvelta) for patients with platinum-resistant ovarian cancer. Findings showed that at the optimized dose of 5.2 mg/kg (with G-CSF support for two cycles, then 4.3 mg/kg), luvelta achieved an overall response rate (ORR) of 32% and a disease control rate (DCR) of 96%. The data revealed encouraging antitumor activity across patients with varying levels of Folate Receptor-α (FRα) expression (25% or greater), demonstrating consistent safety and low discontinuation rates across all dosages. These results suggest that luvelta may offer improved patient responses compared to standard chemotherapy for a key group with unmet medical needs.
Read Announcement- Drug:
- luvelta
- Announced Date:
- December 10, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc. announced the selected dose from the dose-optimization portion (Part 1) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), following a meeting with the U.S. Food and Drug Administration (FDA).
AI Summary
Sutro Biopharma announced that the 5.2 mg/kg starting dose from the dose-optimization stage of its REFRαME-O1 trial has been selected for the randomized, registration-directed study of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer. This decision was made after a meeting with the U.S. Food and Drug Administration (FDA), which supported the safety and efficacy seen at this dose. In the trial’s dose-optimization phase, the 5.2 mg/kg group, which included prophylactic pegfilgrastim for the first two cycles followed by a reduction to 4.3 mg/kg, showed an objective response rate of 32%. The results suggest luvelta could be an effective treatment for patients with varying levels of folate receptor alpha expression, offering a promising new option compared to chemotherapy for this challenging patient population.
Read Announcement- Drug:
- luvelta
- Announced Date:
- September 14, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc announced updated data from the ongoing Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for patients with epithelial ovarian cancer (EOC) in a poster presentation at the 2024 European Society For Medical Oncology (ESMO) Congress in Barcelona, Spain.
AI Summary
Sutro Biopharma recently presented updated data from its ongoing Phase 1b study of luveltamab tazevibulin (luvelta) in combination with bevacizumab for patients with epithelial ovarian cancer at the 2024 ESMO Congress in Barcelona. The study highlighted that at the recommended Phase 2 dose (RP2D) of 4.3 mg/kg of luvelta with a standard bevacizumab dose (15 mg/kg) administered every three weeks, an objective response rate of 56% was observed among patients. Overall, the combination showed encouraging antitumor activity with a 35% response rate across all dose groups. Importantly, the treatment demonstrated promising effects regardless of Folate Receptor-α expression or previous bevacizumab exposure. An expansion phase is currently underway with an additional 23 patients enrolled, and early expansion data are expected in the first half of 2025.
Read Announcement- Drug:
- luvelta
- Announced Date:
- August 22, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc. announced that REFRαME-L1, the global Phase 2 study of luveltamab tazevibulin (luvelta) for patients with non-small cell lung cancer (NSCLC) whose tumor expresses Folate Receptor-α (FRα), has been initiated and is open for enrollment.
AI Summary
Sutro Biopharma, Inc. has initiated the REFRαME-L1 global Phase 2 study, which is now open for enrollment. This clinical trial will evaluate luveltamab tazevibulin (luvelta) in adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express Folate Receptor-α (FRα) at levels equal to or higher than 25% Tumor Proportion Score. The study plans to dose patients with 4.3 mg/kg of luvelta every three weeks. Researchers hope that the treatment’s precise design and wide therapeutic window will provide a new option for patients, including those with lower FRα expression who may not have many alternatives. The study represents a significant step forward in expanding treatment options for NSCLC, particularly for cases where the tumors display elevated levels of FRα, and initial data is anticipated in the first half of 2025.
Read Announcement- Drug:
- luvelta
- Announced Date:
- August 22, 2024
- Estimated Event Date Range:
- January 1, 2025 - June 30, 2025
- Target Action Date:
- 2025-H1
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma, Inc announced that Initial data from this study is expected in the first half of 2025
AI Summary
Sutro Biopharma, Inc. recently announced the global Phase 2 REFRαME-L1 study for their investigational treatment luveltamab tazevibulin (luvelta). The trial focuses on patients with non-small cell lung cancer (NSCLC) that express the Folate Receptor-α (FRα), an important target in many cancers. This study is designed to evaluate the safety and potential benefits of luvelta for patients who have seen few treatment options for their advanced disease.
A major highlight of the announcement is that the initial data from this study is expected in the first half of 2025. This anticipated milestone marks a significant step for Sutro as they work to expand treatment opportunities for patients with FRα-expressing cancers, offering hope for improved outcomes in NSCLC.
Read Announcement- Drug:
- luvelta
- Announced Date:
- April 30, 2024
- Indication:
- Treatment of endometrial cancer
Announcement
Sutro Biopharma announced that the randomized portion (Part 2) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), is now open for enrollment, and the planned 50 patients in Part 1 of the trial have been enrolled. Luvelta is a novel Folate Receptor-α (FRα) targeting ADC with the potential to benefit 8 out of 10 PROC patients, including addressing high unmet medical need in patients with low-medium FRα expression.
AI Summary
Sutro Biopharma announced that Part 2 of its REFRαME-O1 trial—the registration-directed study of luveltamab tazevibulin (luvelta)—for platinum-resistant ovarian cancer is now open for enrollment. This phase of the study will randomly assign patients to receive either the selected luvelta dose or standard chemotherapy. The trial targets women whose tumors express Folate Receptor-α (FRα), including those with low-to-medium expression who currently have limited treatment options.
Additionally, the company has successfully enrolled the planned 50 patients in Part 1, which focused on dose optimization, and these participants are now in follow-up. Luvelta, a novel FRα-targeting antibody-drug conjugate, holds promise for benefiting up to 8 out of 10 patients with platinum-resistant ovarian cancer by offering a new, targeted treatment approach.
Read Announcement
Sutro Biopharma FDA Events - Frequently Asked Questions
As of now, Sutro Biopharma (STRO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sutro Biopharma (STRO) has reported FDA regulatory activity for luvelta.
The most recent FDA-related event for Sutro Biopharma occurred on March 15, 2025, involving luvelta. The update was categorized as "Data," with the company reporting: "Sutro Biopharma, Inc announced expanded data in a late-breaking oral presentation from the dose-optimization portion of the REFRαME-O1 trial with luveltamab tazevibulin (luvelta) in patients with platinum resistant ovarian cancer (PROC) at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer®."
Currently, Sutro Biopharma has one therapy (luvelta) targeting the following condition: Treatment of endometrial cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:STRO) was last updated on 7/10/2025 by MarketBeat.com Staff
