In patients who have human epidermal growth factor receptor 2 (HER2)-positive breast cancer, the use of pertuzumab may be considered medically necessary:
in combination with trastuzumab and a taxane (eg, docetaxel, paclitaxel) for treatment of locally recurrent or metastatic breast cancer if pertuzumab was not previously administered; or
for neoadjuvant treatment of locally advanced, inflammatory, or early-stage (either >2 cm in diameter or node-positive) breast cancer; or
the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
The use of pertuzumab is considered investigational for all other indications, including but not limited to HER2-positive gastric, colorectal, non-small-cell lung, and ovarian cancers; HER2-positive cancers of the gastroesophageal junction; and HER2-negative cancers.
NCCN 2A positioning category for Off label indications:
Extensive Brain Metastases
Used in combination with high-dose trastuzumab as treatment for limited brain metastases in patients with HER2 positive breast cancer may be considered as initial treatment in select patients (eg, patients with small asymptomatic brain metastases) consider as treatment for recurrent brain metastases treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options
Biliary Tract Cancers: Gallbladder Cancer
Subsequent treatment in combination with trastuzumab for progression on or after systemic treatment for unresectable or metastatic disease that is HER2-positive (useful in certain circumstances)
Biliary Tract Cancers: Extrahepatic Cholangiocarcinoma
Subsequent treatment in combination with trastuzumab for progression on or after systemic treatment for unresectable or metastatic disease that is HER2-positive (useful in certain circumstances)
Salivary Gland Tumors
Useful in certain circumstances, in combination with trastuzumab, as systemic therapy for human epidermal growth factor receptor 2 (HER2)-positive recurrent disease with distant metastases in patients with a performance status (PS) of 0-3 unresectable locoregional recurrence or second primary with prior radiation therapy
Colon Cancer
Therapy in combination with trastuzumab (HER2-amplified and RAS and BRAF wildtype) if intensive therapy not recommended and no previous treatment with a HER2 inhibitor as primary treatment for locally unresectable or medically inoperable disease as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction for synchronous unresectable metastases of other sites as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy
Therapy in combination with trastuzumab in patients (HER2-amplified and RAS and BRAF wild-type) if intensive therapy not recommended as adjuvant treatment following resection and/or local therapy for resectable metachronous metastases in patients who have received previous chemotherapy as adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy.
Subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) not previously treated with HER2 inhibitor, in patients previously treated with oxaliplatin-based therapy without irinotecan with irinotecan-based therapy without oxaliplatin with oxaliplatin and irinotecan without irinotecan or oxaliplatin without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab
Initial systemic therapy for advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) in combination with trastuzumab if intensive therapy not recommended and no previous treatment with a HER2 inhibito
Subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) not previously treated with HER2 inhibitor, in patients previously treated with oxaliplatin-based therapy without irinotecan with irinotecan-based therapy without oxaliplatin with oxaliplatin and irinotecan without irinotecan or oxaliplatin without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab
Rectal Cancer
Therapy in combination with trastuzumab in patients (HER2-amplified and RAS and BRAF wild-type) if intensive therapy not recommended and no previous treatment with a HER2 inhibitor as primary treatment for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant or total neoadjuvant therapy as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction as primary treatment for synchronous unresectable metastases of other sites as primary treatment for unresectable isolated pelvic/anastomotic recurrence as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy
Therapy in combination with trastuzumab in patients (HER2-amplified and RAS and BRAF wild-type) if intensive therapy not recommended as adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases in patients who have received previous chemotherapy as adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable response from conversion therapy
Subsequent therapy in combination with trastuzumab for progression of advanced or metastatic disease (HER2-amplified and RAS and BRAF wild-type) not previously treated with HER2 inhibitor, in patients previously treated with oxaliplatin-based therapy without irinotecan with irinotecan-based therapy without oxaliplatin with oxaliplatin and irinotecan without irinotecan or oxaliplatin without irinotecan or oxaliplatin followed by FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) with or without bevacizumab
