Bicara Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Bicara Therapeutics (BCAX).
Over the past two years, Bicara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ficerafusp. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ficerafusp alfa FDA Regulatory Timeline and Events
Ficerafusp alfa is a drug developed by Bicara Therapeutics for the following indication: squamous cancer of the anal canal (SCAC).
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:
- ficerafusp alfa
- Announced Date:
- June 1, 2025
- Indication:
- squamous cancer of the anal canal (SCAC).
Announcement
Bicara Therapeutics Inc. presented updated data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Bicara Therapeutics Inc. recently presented updated data at the 2025 ASCO Annual Meeting from its Phase 1/1b clinical trial. The study evaluates the combination of ficerafusp alfa and pembrolizumab in patients with first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The data shows promising anti-tumor activity, with responders enjoying a median duration of response of 21.7 months. Impressively, 80% of responders achieved a deep response with at least 80% tumor shrinkage. In addition, overall survival outcomes were encouraging, with a median OS of 21.3 months and a two-year OS rate of 46% in HPV-negative patients, a group traditionally facing limited treatment benefits. These results suggest that ficerafusp alfa’s ability to improve tumor penetration may enhance the effects of pembrolizumab, supporting further development in the ongoing pivotal Phase 2/3 FORTIFI-HN01 trial.
Read Announcement- Drug:
- ficerafusp alfa
- Announced Date:
- May 22, 2025
- Indication:
- squamous cancer of the anal canal (SCAC).
Announcement
Bicara Therapeutics Inc. announced the publication of an abstract with updated interim data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website.
AI Summary
Bicara Therapeutics Inc. announced the publication of an abstract on the 2025 ASCO Annual Meeting website featuring updated interim data from its Phase 1/1b trial. The study evaluated ficerafusp alfa, a first-in-class bifunctional antibody, in combination with pembrolizumab in patients with first line recurrent/metastatic head and neck squamous cell carcinoma. The updated data show promising signals of improved overall survival and durable responses, especially in HPV-negative patients who have few treatment options. The results also included supportive tumor biomarker findings that indicate successful targeting of barriers within the tumor microenvironment. Bicara’s full dataset will be shared during an oral presentation at ASCO, with further details provided on a conference call scheduled for June 1, 2025.
Read Announcement- Drug:
- ficerafusp alfa
- Announced Date:
- March 25, 2025
- Indication:
- squamous cancer of the anal canal (SCAC).
Announcement
Bicara Therapeutics Inc. announced that three abstracts relating to the company's lead product candidate, ficerafusp alfa, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, which will be held from April 25-30, 2025 in Chicago, IL.
AI Summary
Bicara Therapeutics Inc. announced that three abstracts on its lead product candidate, ficerafusp alfa, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that targets both the epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) in solid tumors. One abstract will focus on Phase 1/1b dose expansion data in patients with advanced cutaneous squamous cell carcinoma. Another abstract discusses dual blockade with pembrolizumab for head and neck cancer, while the third examines preclinical evidence on overcoming drug resistance in KRAS-G12C-mutated lung tumors.
These presentations highlight the therapy’s potential impact on reversing treatment resistance and improving patient outcomes. Detailed session information, including presentation dates and locations, will be available during the meeting and later on the company website, demonstrating an overall promising impact.
Read Announcement- Drug:
- ficerafusp alfa
- Announced Date:
- February 11, 2025
- Indication:
- squamous cancer of the anal canal (SCAC).
Announcement
Bicara Therapeutics Inc. announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
AI Summary
Bicara Therapeutics Inc. has reached an important milestone with the enrollment of the first patients in its FORTIFI-HN01 trial. This pivotal Phase 2/3 study will evaluate the safety and effectiveness of ficerafusp alfa combined with pembrolizumab as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
Ficerafusp alfa is a first-in-class bifunctional antibody that targets both the epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β). Early Phase 1/1b results have shown promising anti-tumor activity, which has encouraged the transition to this late-stage trial. The study aims to assess overall response rates and survival outcomes, potentially offering a new treatment option for patients facing this challenging and aggressive disease.
Read Announcement- Drug:
- ficerafusp alfa
- Announced Date:
- January 27, 2025
- Indication:
- squamous cancer of the anal canal (SCAC).
Announcement
Bicara Therapeutics Inc. announced the presentation of data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC).
AI Summary
Bicara Therapeutics Inc. announced promising Phase 1/1b data on its new treatment combining ficerafusp alfa with pembrolizumab for patients with advanced squamous cancer of the anal canal (SCAC) who have already undergone at least one chemotherapy. The study was presented at the 2025 ASCO Gastrointestinal Cancers Symposium and involved 28 patients with immune checkpoint inhibitor–naive SCAC. Results showed a 25% overall response rate, with several patients experiencing partial or complete responses. The combination treatment also improved measures like disease control and 12-month progression-free survival, even among patients with liver metastases. Researchers are hopeful that this dual approach, which targets both tumor growth and the tumor’s ability to suppress the immune response, may offer a more effective treatment option for this high-need patient group, warranting further clinical investigation.
Read Announcement
Bicara Therapeutics FDA Events - Frequently Asked Questions
As of now, Bicara Therapeutics (BCAX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Bicara Therapeutics (BCAX) has reported FDA regulatory activity for ficerafusp alfa.
The most recent FDA-related event for Bicara Therapeutics occurred on June 1, 2025, involving ficerafusp alfa. The update was categorized as "Data Presentation," with the company reporting: "Bicara Therapeutics Inc. presented updated data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting."
Currently, Bicara Therapeutics has one therapy (ficerafusp alfa) targeting the following condition: squamous cancer of the anal canal (SCAC)..
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:BCAX) was last updated on 7/16/2025 by MarketBeat.com Staff
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