Therapy Detail

Therapy Name Gefitinib
Therapy Description

Iressa (gefitinib) is a first-generation EGFR inhibitor that binds EGFR and inhibits downstream signaling, potentially resulting in decreased growth of tumors with EGFR activation (PMID: 26980062, PMID: 25302162, PMID: 15284455). Iressa (gefitinib) is FDA approved for use in patients with non-small cell lung cancer harboring an EGFR exon 19 deletion or EGFR L858R (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Gefitinib Iressa ZD1839 EGFR Inhibitor (Pan) 38 EGFR Inhibitor 1st gen 3 Iressa (gefitinib) is a first-generation EGFR inhibitor that binds EGFR and inhibits downstream signaling, potentially resulting in decreased growth of tumors with EGFR activation (PMID: 26980062, PMID: 25302162, PMID: 15284455). Iressa (gefitinib) is FDA approved for use in patients with non-small cell lung cancer harboring an EGFR exon 19 deletion or EGFR L858R (FDA.gov).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
KRAS G12X lung adenocarcinoma predicted - resistant Gefitinib Clinical Study Actionable In a clinical study, KRAS codon 12 or 13 mutations were correlated with a lack of response to Iressa (gefitinib) in patients with lung adenocarcinoma (PMID: 15696205). 15696205
ERBB2 R678Q Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
KRAS G12S lung adenocarcinoma no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, lung adenocarcinoma cells harboring KRAS G12S were insensitive to treatment with Iressa (gefitinib) in culture, demonstrating minimal inhibition of cell growth (PMID: 29925635). 29925635
ERBB2 V659E lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) V659E did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 L726I breast cancer resistant Gefitinib Preclinical Actionable In a preclinical study, an ERBB2 (HER2) L726I mutation was detected in a murine breast cancer cell line that acquired resistance to Iressa (gefitinib) in culture (PMID: 17638894). 17638894
ERBB2 L755_T759del breast cancer sensitive Gefitinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) L755_T759del were sensitive to treatment with Iressa (gefitinib) (PMID: 23220880). 23220880
ERBB2 Y772_A775dup lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ROS1 rearrange non-small cell lung carcinoma no benefit Gefitinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ROS1 rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ERBB2 G776delinsVC non-small cell lung carcinoma resistant Gefitinib Preclinical Actionable In a preclinical study, non-small cell lung cancer cells harboring ERBB2 (HER2) G776delinsVC demonstrated resistance to treatment with Iressa (gefitinib) in culture (PMID: 26545934). 26545934
KRAS G13X lung adenocarcinoma resistant Gefitinib Clinical Study Actionable In a clinical study, KRAS codon 12 or 13 mutations correlated with a lack of response to Iressa (gefitinib) in patients with lung adenocarcinoma (PMID: 15696205). 15696205
ERBB2 amp lung squamous cell carcinoma resistant Gefitinib Preclinical Actionable In a preclinical study, a lung squamous cell carcinoma cell line with ERBB2 (HER2) amplification demonstrated resistance to treatment with Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G660D Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G776delinsVC lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G776delinsVC did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
KRAS amp MET del exon14 non-small cell lung carcinoma no benefit Gefitinib Preclinical - Patient cell culture Actionable In a preclinical study, Iressa (gefitinib) treatment did not result in apoptotic induction or inhibition of cell proliferation in non-small cell lung carcinoma patient-derived cells harboring KRAS amplification and a MET exon 14 splice site mutation (PMID: 30072474). 30072474
ERBB2 G776delinsLC lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G776delinsLC did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 L663P Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ALK rearrange non-small cell lung carcinoma no benefit Gefitinib Guideline Actionable EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) are not indicated for use as subsequent therapy in ALK rearranged non-small cell lung cancer patients who relapsed on Alecensa (alectinib), Xalkori (crizotinib), or Zykadia (ceritinib) (NCCN.org). detail...
ERBB2 G660R Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G778_P780dup lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
KRAS mutant non-small cell lung carcinoma no benefit Gefitinib Guideline Actionable KRAS mutations are associated with lack of efficacy with EGFR tyrosine kinase inhibitors including Tarceva (erlotinib), Iressa (gefitinib), Gilotrif (afatinib), and Tagrisso (osimertinib) in patients with non-small cell lung cancer (NCCN.org). detail...
ERBB2 V659E Advanced Solid Tumor predicted - resistant Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G660D lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells cells expressing ERBB2 (HER2) G660D did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
Clinical Trial Phase Therapies Title Recruitment Status
NCT02296125 Phase III Erlotinib Osimertinib Gefitinib AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Active, not recruiting
NCT02551718 Phase I Bosutinib Irinotecan romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Recruiting
NCT02088112 Phase I Gefitinib Durvalumab MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC) Active, not recruiting
NCT02179671 Phase II Selumetinib + Docetaxel Gefitinib Durvalumab Osimertinib Tremelimumab Immune-Modulated Study of Selected Small Molecules (Gefitinib, AZD9291, or Selumetinib + Docetaxel) or a 1st Immune-Mediated Therapy (IMT; Tremelimumab) With a Sequential Switch to a 2nd IMT (MEDI4736) in Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Completed
NCT02588261 Phase III Naquotinib Gefitinib Erlotinib A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations Terminated
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifine Crizotinib Dactinomycin Temsirolimus Vorinostat romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Recruiting