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FDA Approved EGFR Inhibitors

Generic NameBrand NameDosage FormTargetAdditional TargetsCompanyTickerFDA Approved IndicationsApproval
AfatinibGilotrifOral TabletsEGFRHER2, HER4Boehringer IngelheimPrivateFirst-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutationsFull
AfatinibGilotrifOral TabletsEGFRHER2, HER4Boehringer IngelheimPrivateTreatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.Full
CetuximabErbituxIntravenous InfectionEGFRNoneEli LillyLLYIn combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN)Full
CetuximabErbituxIntravenous InfectionEGFRNoneEli LillyLLYIn combination with platinum-based therapy with fluorouracil for the first-line treatment of patients with recurrent locoregional disease or metastatic SCCHNFull
CetuximabErbituxIntravenous InfectionEGFRNoneEli LillyLLYAs a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failedFull
CetuximabErbituxIntravenous InfectionEGFRNoneEli LillyLLYIn combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC)Full
CetuximabErbituxIntravenous InfectionEGFRNoneEli LillyLLYIn combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy for the treatment of K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC)Full
CetuximabErbituxIntravenous InfectionEGFRNoneEli LillyLLYAs a single agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan for K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC)Full
DacomitinibVizimproOral TabletsEGFRHER2, HER4, DDR1, EPHA6, LCK, DDR2, MNK1PfizerPFEFor the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutationsFull
ErlotinibTarcevaOral TabletsEGFRNoneGenentech (Roche)RHHBYTreatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimenFull
ErlotinibTarcevaOral TabletsEGFRNoneGenentech (Roche)RHHBYFirst-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabineFull
GefitinibIressaOral TabletsEGFRNoneAstraZenecaAZNFirst-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations Full
LapatinibTykerbOral TabletsEGFRHER2NovartisNVSIn combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors
overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
Full
LapatinibTykerbOral TabletsEGFRHER2NovartisNVSIn combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.Full
NecitumumabPortrazzaIntravenous InfectionEGFRNoneEli LillyLLYFirst-line treatment of patients with metastatic squamous non-small cell lung cancer in combination with gemcitabine and cisplatinFull
NeratinibNerlynxOral TabletsEGFRHER2, HER4Puma BiotechnologyPBYIExtended adjuvant treatment of adult patients with early-stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer, to follow adjuvant trastuzumab based therapy.Full
NeratinibNerlynxOral TabletsEGFRHER2, HER4Puma BiotechnologyPBYITreatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting in combination with capecitabine.Full
OsimertinibTagrissoOral TabletsEGFRNoneAstraZenecaAZNFirst-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations Full
OsimertinibTagrissoOral TabletsEGFRNoneAstraZenecaAZNTreatment of patients with metastatic EGFR T790M mutation-positive NSCLC whose disease has progress on or after EGFR tyrosine kinase inhibitor therapyFull
PanitumumabVectibixIntravenous InfectionEGFRHER2, HER3, HER4AmgenAMGNIn combination with FOLFOX for first-line treatment of wild-type RAS metastatic colorectal cancer (mCRC)Full
PanitumumabVectibixIntravenous InfectionEGFRHER2, HER3, HER4AmgenAMGNAs monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy for the treatment of wild-type RAS metastatic colorectal cancer (mCRC)Full
VandetanibCaprelsaOral TabletsEGFRVEGFR, RET, BRK, TIE2, EPH, and Src kinaseSanofiSNYTreatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic diseaseFull

The FDA’s Accelerated Approval program aims to promote earlier approval of drugs to fill an unmet medical need. As such, approval is based on a surrogate endpoint (laboratory measurement, tumor shrinkage, physical sign) that is thought to predict a clinical benefit. Use of surrogate endpoint(s) results in a shorter time in development prior to FDA approval.

If a company receives accelerated approval, they are still required to conduct an additional study to confirm the assumed clinical benefit. If the confirmatory trial shows a clinical benefit, then the FDA will grant traditional (“full”) approval. If the confirmatory trial does not show a clinical benefit, the FDA may elect to remove the drug from the market.

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