Today, our
@SclcSMASHERS received unfortunate news regarding infintamab deruxtecan (I-DXd).
As you may recall, I-DXd is a B7-H3 directed antibody-drug conjugate (i.e., chemotherapy as a biological Trojan horse) that has been studied in SCLC.
We have been anticipating the
@FDA would complete their PDUFA process for accelerated approval of I-DXd by October 2026.
Unfortunately, the company Merck (along with the Rx developer Daichii Sankyo) has WITHDRAWN their application from the FDA for accelerated approval today.
The company expressed concerns that I-DXd may have not been approved with only Phase 2 study findings (IDEATE-LUNG-01, which were positive with high # of responses with brisk time to response) and the Phase 3 study (IDEATE-LUNG-02) is nearing completion.
While I am hopeful that the Phase 3 data for I-DXd in the future, given two positive Phase 3 studies (Tam-Peli and Riz-Rez) at
#WCLC26, this update makes it especially challenging, with lurbinectedin being revoked as well for patients who need options for relapsed SCLC, post tarlatamab.
🚨 I cannot emphasize enough that more clinical trials & agents in the space are vital, CLEAR unmet needs exist, and trials should be discussed with our patients at every major treatment decision in
#SCLC to improve the care for every patient impacted by SCLC.
@LUNGevity @lungoncdoc @StephenVLiu @alissajcooper @Sonampuri @BZhangMD @LaurenByersMD @BalazsHalmosMD @OncBrothers @OncoAlert @OncLive @YoungLungCancer @Lung_Cancers @RManochakian @Latinamd @TheShieldsLab @lcrf_org @LungCancerEu @oncodaily #lcsm