Onco-Summaries: Daily Oncology Updates at a Glance
07/10/2026
US FDA approves tucatinib-based maintenance regimen for HER2-positive Breast Cancer
US FDA grants two breakthrough therapy designations to AbbVie’s c-Met ADC Temab-A in CRC and NSCLC (Ref)
AbbVie announced that the US FDA has granted two Breakthrough Therapy Designations (BTDs) to c-Met-targeted antibody-drug conjugate (ADC), telisotuzumab adizutecan (Temab-A/ABBV-400)
Metastatic Colorectal Cancer (CRC): BTD granted for Temab-A in combination with bevacizumab for patients with refractory metastatic CRC who have progressed after standard treatments.
Non-Small Cell Lung Cancer (NSCLC): BTD granted for Temab-A monotherapy in patients with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing non-squamous NSCLC who have received prior platinum chemotherapy and anti-PD-(L)1 therapy
Designations were granted based on results from the ongoing first-in-human study M21-404/NCT05029882
US FDA approves tucatinib-based maintenance regimen for HER2-positive Breast Cancer (Ref)
Pfizer announced US FDA approval of TUKYSA (tucatinib; HER2-TKI) plus trastuzumab and pertuzumab as a front-line maintenance treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction therapy
Approval was based on results from the Phase 3 HER2CLIMB-05 trial
The regimen reduced the risk of disease progression or death by 35.9% versus trastuzumab + pertuzumab alone (HR 0.64; p<0.0001)
Median progression-free survival (PFS) improved to 24.9 months versus 16.3 months for control, an improvement of 8.6 months
Overall survival data were not mature at the time of analysis
The safety profile was consistent with the known profile of tucatinib
The recommended dose of tucatinib is 300 mg orally twice daily in combination with trastuzumab and pertuzumab until disease progression or unacceptable toxicity
The approval moves TUKYSA earlier in the HER2+ metastatic breast cancer treatment pathway, potentially expanding the eligible patient population
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