Tykerb (lapatinib) — United Healthcare
Rectal Cancer
Initial criteria
- Diagnosis of rectal cancer
- AND Disease is HER2-amplified and RAS and BRAF wild-type
- AND One of the following:
- Disease is proficient mismatch repair/microsatellite-stable (pMMR/MSS)
- OR Disease is positive for deficient mismatch repair/microsatellite instability-high (dMMR/MSI-H) or polymerase epsilon/delta (POLE/POLD1) mutation AND (Ineligible for or progressed on checkpoint inhibitor immunotherapy [e.g., Opdivo, Keytruda, Jemperli] OR contraindication to immunotherapy)
- AND One of the following:
- Used as initial therapy for unresectable metachronous metastases AND previous therapy with FOLFOX or CapeOX within the past 12 months
- OR Intensive chemotherapy with oxaliplatin, irinotecan, or capecitabine is not recommended
- OR Used as second-line or subsequent therapy for progression of advanced/metastatic disease
- AND Used in combination with trastuzumab
- AND Patient has not previously been treated with a HER2 inhibitor [e.g., trastuzumab, Perjeta (pertuzumab), Nerlynx (neratinib)]
Reauthorization criteria
- Patient does not show evidence of progressive disease while on Tykerb therapy
Approval duration
12 months