MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis. Ulcerative keratitis is an ophthalmological emergency. Patients undergoing treatment with EGFR inhibitors who present with acute or worsening signs and symptoms suggestive of keratitis should be referred promptly to an ophthalmology specialist. Refer to MHRA Drug Safety Update for more information.

Cetuximab

• Solution for infusion vials 100mg/20ml, 500mg/100ml

Notes

1. NICE TA145: Cetuximab (Erbitux) in combination with radiotherapy is recommended as a treatment option only for patients with locally advanced squamous cell cancer of the head and neck whose Karnofsky performance-status score is 90% or greater and for whom all forms of platinum-based chemoradiotherapy treatment are contraindicated (June 2008).
2. NICE TA473: Cetuximab (Erbitux) in combination with platinum-based chemotherapy is recommended as an option for treating recurrent or metastatic squamous cell cancer of the head and neck in adults (August 2017), only
   1. if the cancer started in the oral cavity and
   2. when the company provides the drug in line with the commercial access agreement with NHS England.
3. NICE TA242: Cetuximab (Erbitux) monotherapy or combination chemotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy (January 2012).
4. NICE TA439: Cetuximab (Erbitux) is recommended, within its marketing authorisation, as an option for previously untreated epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer in adults in combination with (November 2017):
   1. 5‑fluorouracil, folinic acid and oxaliplatin (FOLFOX) or
   2. 5‑fluorouracil, folinic acid and irinotecan (FOLFIRI)
   3. Cetuximab is recommended only when the company provides it with the discount agreed in the commercial access agreement.
5. NICE TA668: Encorafenib (Braftovi) plus cetuximab (Erbitux) is recommended, within its marketing authorisation, as an option for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment. It is recommended only if the company provides it according to the commercial arrangements (January 2021)
6. MHRA Drug Safety Update (February 2014): Cetuximab: new safety information on the importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer

Dacomitinib

• Tablets 15mg, 30mg, 45mg

Notes

1. NICE TA595: Dacomitinib (Vizimpro) is recommended, within its marketing authorisation, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. It is recommended only if the company provides it according to the commercial arrangement (August 2019).

Erlotinib

• Tablets 25mg, 100mg, 150mg

Notes

1. NICE TA227: Erlotinib (Tarceva) monotherapy is not recommended for maintenance treatment in people with locally advanced or metastatic non-small cell lung cancer who have stable disease after platinum-based first-line chemotherapy (June 2011).
2. NICE TA258: Erlotinib (Tarceva) is recommended as an option for the first-line treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) (June 2012) if:
   1. they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and
   2. the manufacturer provides erlotinib at the discounted price agreed under the patient access scheme.
3. NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (December 2015):
   1. Erlotinib (Tarceva) is recommended as an option for treating locally advanced or metastatic non‑small‑cell lung cancer that has progressed in people who have had non‑targeted chemotherapy because of delayed confirmation that their tumour is epidermal growth factor receptor tyrosine kinase (EGFR‑TK) mutation‑positive, only if the company provides erlotinib with the discount agreed in the patient access scheme revised in the context of NICE TA258..
   2. Erlotinib (Tarceva) is recommended as an option for treating locally advanced or metastatic non-small-cell lung cancer that has progressed after non-targeted chemotherapy in people with tumours of unknown EGFR-TK mutation status, only if:
      • the result of an EGFR-TK mutation diagnostic test is unobtainable because of an inadequate tissue sample or poor quality DNA and
      • the treating clinician considers that the tumour is very likely to be EGFR-TK mutation positive and
      • the person's disease responds to the first 2 cycles of treatment with erlotinib and
      • the company provides erlotinib with the discount agreed in the patient access scheme revised in the context of NICE TA258.
   3. Erlotinib (Tarceva) is not recommended for treating locally advanced or metastatic non‑small‑cell lung cancer that has progressed after non‑targeted chemotherapy in people with tumours that are EGFR‑TK mutation‑negative.
4. MHRA Drug Safety Update (June 2009): Erlotinib: new safety information for intensive monitoring.

Gefitinib

• Tablets 250mg

Notes

1. NICE TA192: Gefitinib (Iressa) is recommended as an option for the first-line treatment of people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) (July 2010) if:
   1. they test positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and
   2. the manufacturer provides gefitinib at the fixed price agreed under the patient access scheme.
2. NICE TA374: Gefitinib (Iressa) is not recommended for treating locally advanced or metastatic non small cell lung cancer that has progressed after non targeted chemotherapy in people with tumours that are EGFR-TK mutation positive (December 2015).

Osimertinib

• Tablets 40mg, 80mg

Notes

1. NICE TA653: Osimertinib (Tagrisso) is recommended as an option for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults (October 2020), only if:
   1. their disease has progressed after first-line treatment with an EGFR tyrosine kinase inhibitor and
   2. the company provides osimertinib according to the commercial arrangement.
2. NICE TA654: Osimertinib (Tagrisso) is recommended, within its marketing authorisation, as an option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) in adults. It is recommended only if the company provides osimertinib according to the commercial arrangement (October 2020).

Panitumumab

• Solution for infusion vials 100mg/5ml, 400mg/20ml

Notes

1. NICE TA242: Panitumumab (Vectibix) monotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy (January 2012).
2. NICE TA439: Panitumumab (Vectibix) is recommended as an option for previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with (November 2017):
   1. 5‑fluorouracil, folinic acid and oxaliplatin (FOLFOX) or
   2. 5‑fluorouracil, folinic acid and irinotecan (FOLFIRI)
   3. Panitumumab is recommended only when the company provides it with the discount agreed in the patient access scheme.
3. MHRA Drug Safety Update (May 2010): Panitumumab (Vectibix): serious hypersensitivity reactions.
4. MHRA Drug Safety Update (September 2012): Panitumumab (Vectibix): risk of necrotising fasciitis in patients treated with panitumumab in combination with chemotherapy.
5. MHRA Drug Safety Update (September 2013): Panitumumab (Vectibix): importance of establishing wildtype RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer.

Necitumumab

• NICE TA411: Necitumumab (Portrazza), in combination with gemcitabine and cisplatin, is not recommended within its marketing authorisation for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)- expressing squamous non-small-cell lung cancer that has not been treated with chemotherapy (September 2016).