PanTRKare™ Officially Approved as the Companion Diagnostic for VELMARTO® (Eratrectinib)
Published Time:
2026-08-12 17:43
Source:
August 6，the NMPA granted approval to Geneseeq’s PanTRKare™ NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO® (Eratrectinib), a next‑generation highly selective TRK inhibitor independently developed by Vcare PharmaTech. The approval provides critical support for the precise identification and clinical medication of patients with NTRK fusion‑positive solid tumors.
As the original companion diagnostic for Eratrectinib, PanTRKare™ addresses key testing challenges including the pan‑tumor distribution, low incidence and complex fusion patterns of NTRK1/2/3 fusions, enabling accurate detection of NTRK fusion variants across diverse cancer types. Following clinical accuracy validation, bridging study results demonstrated that patients tested positive by PanTRKare™ achieved objective response rates highly consistent with those observed in the drug’s clinical trials, in both treatment‑naïve and pre‑treated populations. This further validates the assay’s stability and consistency for companion diagnostic applications.
Eratrectinib marks Nanjing’s first innovative drug approval this year. Through innovative cyclic structural optimization, it delivers more potent and highly selective inhibition of TRK kinases, overcoming structural limitations and drug‑resistance drawbacks of first‑generation agents at the molecular‑mechanism level. The pivotal VC004‑101 clinical trial has comprehensively verified Eratrectinib’s clinical efficacy and long‑term patient benefits. Study data revealed an overall ORR of 68.5% for Eratrectinib. Among patients with follow‑up exceeding six months, the ORR rose further to 89.7%, representing clinically meaningful improvement superior to first‑generation TRK inhibitors.
In terms of long‑term therapeutic benefit, Eratrectinib exhibited favorable PFS and DOR, with a 2‑year PFS rate of 75.7% and a 2‑year DOR rate of 85.5%. These findings confirm its capacity to deliver durable disease control and sustained remission for patients. It also demonstrates prominent advantages in long‑term survival outcomes by effectively prolonging overall survival; the median OS reached 40.7 months, bringing substantial long‑term survival benefits to patients.
Both Vcare PharmaTech and Geneseeq are enterprises located in the Life Science & Health Industry Office of Nanjing Jiangbei New Area, with a solid long‑term collaborative foundation. Eratrectinib gained marketing approval in June this year, and merely two months later, PanTRKare™ obtained approval for its companion diagnostic use. This completes a key link in the diagnosis‑treatment workflow for NTRK‑fusion solid tumors, creating favorable conditions for post‑launch patient identification, clinical implementation and market adoption, and enabling eligible NTRK‑positive patients to access Eratrectinib targeted therapy at an earlier time point. Such expedited dual approvals fully illustrate the synergistic value brought by the strong partnership between the two parties. It also underscores the industrial ecosystem strengths of Life Science & Health Industry Office of Nanjing Jiangbei New Area in connecting upstream‑downstream industrial chains and empowering collaborative innovation among resident enterprises.
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