EGFR Inhibitors Approved by the FDA^a

Brand Name (Generic Drug Name)

Indications

Caprelsa (vandetanib)¹

Treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease

Erbitux (cetuximab)²

In combination with radiation therapy for the treatment of patients with locally or regionally advanced head and neck squamous cell carcinoma

In combination with fluorouracil for the treatment of patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck

Treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma of the head and neck that progressed after platinum-based therapy

In combination with FOLFIRI for the first-line treatment of patients with K-RAS wild-type, EGFR-expressing, metastatic CRC determined by an FDA-approved test

In combination with irinotecan for the treatment of patients with K-RAS wild-type, EGFR-expressing, metastatic CRC refractory to irinotecan-based chemotherapy, as determined by an FDA-approved test

Treatment of patients with K-RAS wild-type, EGFR-expressing, metastatic CRC unresponsive to oxaliplatin- and irinotecan-based chemotherapy or for patients who are intolerant to irinotecan

Treatment of patients with K-RAS wild-type, EGFR-expressing, metastatic CRC who are intolerant to irinotecan

In combination with encorafenib for the treatment of adults with metastatic, BRAF V600E mutation-positive CRC determined by an FDA-approved test who have received prior therapy

Exkivity (mobocertinib)³

Treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations determined by an FDA-approved test that progressed during or after platinum-based chemotherapy

Gilotrif (afatinib)⁴

First-line treatment of patients with metastatic NSCLC with non-resistant EGFR mutations detected by an FDA-approved test

Treatment of patients with metastatic, squamous NSCLC that progressed after

platinum-based chemotherapy

Iressa (gefitinib)⁵

First-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations detected by an FDA-approved test

Portrazza (necitumumab)⁶

In combination with gemcitabine and cisplatin for the first-line treatment of patients with metastatic, squamous NSCLC

Tagrisso (osimertinib)⁷

Adjuvant therapy after tumor resection in adults with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

First-line treatment of adults with metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

Treatment of adults with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, that progressed during or after EGFR TKI therapy

Tarceva (erlotinib)⁸

Treatment of patients with metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations detected by an FDA-approved test receiving first-line, maintenance, or second- or greater-line treatment after progression with at least 1 prior chemotherapy regimen

In combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer

Vectibix (panitumumab)⁹

In combination with FOLFOX for the first-line treatment of patients with metastatic, wild-type RAS CRC

Treatment of patients with metastatic, wild-type RAS CRC that progressed with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy

Vizimpro (dacomitinib)¹⁰

First-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations detected by an FDA-approved test

EGFR Inhibitors in the Pipeline^b

Generic Drug Name

Potential Indications

BCA101¹¹

Being evaluated for the treatment of patients with cutaneous squamous cell carcinoma; in combination with pembrolizumab for the treatment of patients with head and neck squamous cell carcinoma and squamous carcinoma of the anal canal

EQ143, HS-10296 (aumolertinib)¹²

Being evaluated for the treatment of patients with EGFR-mutated NSCLC

Furmonertinib¹³

Being evaluated for the treatment of patients with advanced or metastatic NSCLC

Tagrisso (osimertinib)¹⁴

Being evaluated in combination with Koselugo or Orpathys for advanced EGFR-mutant NSCLC; in combination with CTx FLAURA2 for the first-line treatment of advanced EGFR-mutant NSCLC; in combination with Orpathys for advanced EGFR-mutant NSCLC; in combination with Orpathys for advanced EGFR-mutant NSCLC; in combination with CTx for the neoadjuvant treatment of stage II/III resectable EGFR-mutant NSCLC; for the adjuvant treatment of EGFR-mutant NSCLC; for the adjuvant treatment of stage Ia2-Ia3 EGFR-mutant NSCLC after complete tumor resection; for the treatment of stage III EGFR-mutant NSCLC; for the second-line treatment of EGFR-mutant, osimertinib-resistant NSCLC

CRC, colorectal cancer; EGFR, epidermal growth factor receptor; FOLFIRI, leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan; FOLFOX, leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin; NSCLC, non-small-cell lung cancer.

^aAdapted from prescribing information.^1-10

^b Adapted from manufacturer websites.^11-14