# Imfinzi recommended for approval in the EU by CHMP

- Link: https://www.directorstalkinterviews.com/imfinzi-recommended-for-approval-in-the-eu-by-chmp/412947851
- Published: 2020-12-15T07:35:41+00:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Imfinzi_ (durvalumab) has been recommended for marketing authorisation in the European
Union for an additional dosing option, 1,500mg fixed dose every four weeks, in the
approved indication of locally advanced, unresectable non-small cell lung cancer(
NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and 
whose disease has not progressed following platinum-based chemoradiation therapy(
CRT).

This new dosing option is consistent with the approved _Imfinzi_ dosing in extensive-
stage small cell lung cancer (ES-SCLC) and once approved, will be available to patients
with locally advanced, unresectable NSCLC weighing more than 30kg.

Following review of the application under its accelerated assessment procedure, 
the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency based its positive opinion on data from several _Imfinzi_ clinical trials,
including the PACIFIC Phase III trial which supported the two-week, weight-based
dosing of 10mg/kg every two weeks already approved in locally advanced, unresectable
NSCLC, and the CASPIAN Phase III trial which used fixed dosing every four weeks 
during maintenance treatment in ES-SCLC.

> **José Baselga, Executive Vice President, Oncology R&D, said:** “The four-week
> dosing regimen will decrease the risk of exposure to infection in the healthcare
> setting, furthering our efforts to ensure continuity of care for cancer patients
> at high risk of complications during the pandemic. We look forward to offering
> non-small cell lung cancer patients in Europe an option that would reduce medical
> visits by extending dosing from two to four weeks.”

_Imfinzi_ was recently approved in the US for this dosing regimen. _Imfinzi_ is 
approved in the curative-intent setting of unresectable, Stage III (locally advanced)
NSCLC after CRT in the EU, US, Japan, China and many other countries, based on the
PACIFIC Phase III trial. Additionally, it is approved in the EU, US, Japan and many
other countries around the world for the treatment of ES-SCLC based on the CASPIAN
Phase III trial.

**Stage III NSCLC**

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (
IIIA, IIIB and IIIC), defined by how much the cancer has spread locally and the 
possibility of surgery.^(1) Stage III disease is different from Stage IV disease,
when the cancer has spread (metastasised), as the majority of Stage III patients
are currently treated with curative intent.^(1,2)

Stage III NSCLC represents approximately one third of NSCLC incidence and in 2015
was estimated to affect nearly 200,000 patients in the following eight large countries:
China, France, Germany, Italy, Japan, Spain, UK, and the US, with approximately 
43,000 cases in the US alone.^(3,4) The majority of Stage III NSCLC patients are
diagnosed with unresectable tumours.^(5) Prior to approval of _Imfinzi_ in this 
setting, no new treatments beyond CRT had been available to patients for decades.
^(6-8)

**Small cell lung cancer**

SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs
and progresses rapidly, despite initial response to chemotherapy.^(9,10) About two
thirds of SCLC patients are diagnosed with extensive-stage disease, in which the
cancer has spread widely through the lung or to other parts of the body.^(11) Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive five years after
diagnosis.^(11)

**Imfinzi**

_Imfinzi_ (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks
the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading
tactics and releasing the inhibition of immune responses.

_Imfinzi_ is also approved for previously treated patients with advanced bladder
cancer in the US and several other countries.

As part of a broad development programme, _Imfinzi_ is also being tested as a monotherapy
and in combinations including with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new medicine, as a treatment for patients with NSCLC, SCLC, bladder
cancer, head and neck cancer, liver cancer, biliary tract cancer, oesophageal cancer,
gastric cancer, cervical cancer and other solid tumours.

**AstraZeneca in lung cancer**

AstraZeneca has a comprehensive portfolio of approved and potential new medicines
in late-stage development for the treatment of different forms of lung cancer spanning
different histologies, several stages of disease, lines of therapy and modes of 
action.

An extensive Immuno-Oncology (IO) development programme focuses on lung cancer patients
without a targetable genetic mutation which represents up to three-quarters of all
patients with lung cancer.^(12) _Imfinzi_, an anti-PDL1 antibody, is in development
for patients with advanced disease (POSEIDON and PEARL Phase III trials) and for
patients in earlier stages of disease including potentially-curative settings (MERMAID-
1, MERMAID-2, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC
Phase III trials) both as monotherapy and in combination with tremelimumab and/or
chemotherapy.

_Imfinzi_ is also in development in the NeoCOAST, COAST and HUDSON Phase II trials
in combination with potential new medicines from the early-stage pipeline including
_Enhertu_ (trastuzumab deruxtecan).

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