On November 11, 2026, Abbisko Therapeutics
Co., Ltd. (Abbisko Therapeutics) announced that the U.S. Food and Drug
Administration (FDA) had approved PIMJETMI® (pimicotinib), an oral
small-molecule colony-stimulating factor 1 receptor (CSF-1R) inhibitor, for adults
with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical
resection may cause worsening functional limitation or severe morbidity.
As a clinical research partner supporting
PIMJETMI®, Tigermed congratulates Abbisko Therapeutics and the entire study
team on this important milestone. Following approvals in China, Canada and
Switzerland, this marks the fourth global marketing authorization for PIMJETMI®,
representing further progress in its global development and commercialization.
Clinical Evidence Supporting a New
Treatment Option for TGCT
TGCT is a rare, locally aggressive tumor
that primarily affects joints, tendon sheaths, and bursae. Patients often
experience pain, swelling, stiffness, and limited joint mobility, which can
significantly impair daily functioning and quality of life. Independently
developed by Abbisko Therapeutics, PIMJETMI® is an oral small-molecule CSF-1R
inhibitor, for which exclusive global commercialization rights have been
licensed to Merck KGaA, Darmstadt, Germany.
The approval was based on results from the
Phase 3 MANEUVER trial and its open-label extension.
At Week 25, PIMJETMI® demonstrated an objective
response rate (ORR) of 56%, compared with 3.2% for placebo, as assessed by
blinded independent central review (BICR) according to RECIST v1.1. Significant
improvements were also observed in active range of motion, physical
functioning, and pain compared with placebo.
Longer-term follow-up data presented at
ESMO 2025 further supported the durability of response. Among patients who
achieved a response at Week 25, 77% maintained clinical benefit after an
additional 12 months of follow-up.
Tigermed's Clinical Research Expertise
Supporting Global Development
Throughout the clinical development of
PIMJETMI®, Tigermed worked closely with Abbisko Therapeutics to support the Phase
3 MANEUVER trial across China, North America, and Europe.
Tigermed provided global clinical
operations, project management, and data management services, working closely
with the Abbisko team to advance study execution and achieve key project
milestones ahead of schedule.
Michael Wen, Director and President of
Tigermed, commented:
"Congratulations to Abbisko
Therapeutics on the U.S. FDA approval of PIMJETMI®. This milestone is a
testament to Abbisko's commitment to innovation and global clinical development.
It also reflects the dedication of investigators, clinical trial participants,
and all partners involved. We sincerely appreciate Abbisko's trust and look
forward to continuing our collaboration, providing high-quality clinical
research services to support global development and help bring innovative
therapies to patients worldwide."
Advancing Global Clinical Development
Through Collaboration
Bringing innovative therapies from
discovery to clinical validation and ultimately to patients requires rigorous
research and close collaboration. Tigermed is proud to have contributed to the
development of PIMJETMI® through its clinical research expertise and global
delivery capabilities.
Tigermed remains committed to strengthening
its global clinical development services and cross-regional collaboration,
supporting biopharmaceutical partners in advancing innovative therapies through
high-quality clinical research.
References
- Abbisko Therapeutics. PIMJETMI® (pimicotinib) Developed by
Abbisko Therapeutics and Licensed by Merck KGaA, Darmstadt, Germany
Receive U.S. FDA Approval for TGCT. November 2026.
- U.S. Food and Drug Administration. FDA Approves Pimicotinib
for Symptomatic Tenosynovial Giant Cell Tumor. November 10, 2026.
