Crizotinib in bronchial carcinoma: New data not informative

October 06, 2016

Crizotinib (trade name: Xalkori) has been available since 2012 for patients with advanced non-small cell lung cancer (bronchial carcinoma) with high activity of the enzyme anaplastic lymphoma kinase (ALK) who have already received another treatment. The drug had already undergone a dossier assessment, but the Federal Joint Committee (G-BA) had limited its decision, which is why the drug manufacturer now submitted a new dossier.

The Institute for Quality and Efficiency in Health Care (IQWiG) has now also assessed this second dossier: It contained new results from a later data cut-off for patients for whom further chemotherapy is an option. These were not interpretable in a meaningful way, however, which was mainly due to the increased proportion of patients who had switched treatment.

Again, the drug manufacturer did not submit any data for further patients. The result of the first dossier assessment is therefore still valid.

87% of the participants in the chemotherapy arm switched to crizotinib

In the study that was decisive already for the first assessment, patients could be switched from the chemotherapy arm to the crizotinib arm of the study under certain conditions such as progression. Such treatment switching causes problems. It was unclear, for example, how long the patients initially allocated to the chemotherapy arm would have lived if, after progression, they had continued treatment with a different chemotherapy instead of crizotinib.

At the second data cut-off, the proportion of patients who had switched treatment had increased to 87% (first data cut-off: 62%). Thus, the study almost only consisted of one (crizotinib) arm, however, which limited the interpretability of the data considerably further than this was the case at the first data cut-off.

Still advantage in symptoms and quality of life

Due to the increased uncertainty, the second dossier contained no new findings in comparison with the first assessment, which also comprised an addendum. Hence, its results remained unchanged: For patients for whom chemotherapy principally is still an option, there is a hint of a considerable added benefit of crizotinib in comparison with chemotherapy for the outcomes on symptoms and health-related quality of life.

For patients for whom chemotherapy is no longer indicated, also the second dossier contained no data.

G-BA decides on the extent of added benefit

The dossier assessment is part of the early benefit assessment according to the Act on the Reform of the Market for Medicinal Products (AMNOG) supervised by the G-BA. After publication of the dossier assessment, the G-BA conducts a commenting procedure and makes a final decision on the extent of the added benefit.
More English-language information will be available soon (Sections 2.1 to 2.5 of the dossier assessment as well as easily understandable information on If you would like to be informed when these documents are available, please send an e-mail to

Institute for Quality and Efficiency in Health Care

Related Chemotherapy Articles from Brightsurf:

Chemotherapy is used to treat less than 25% of people with localized sarcoma
UCLA researchers have found that chemotherapy is not commonly used when treating adults with localized sarcoma, a rare type of cancer of the soft tissues or bone.

Starved cancer cells became more sensitive to chemotherapy
By preventing sugar uptake, researchers succeeded in increasing the cancer cells' sensitivity to chemotherapeutic treatment.

Vitamin D could help mitigate chemotherapy side effects
New findings by University of South Australia researchers reveal that Vitamin D could potentially mitigate chemotherapy-induced gastrointestinal mucositis and provide relief to cancer patients.

Less chemotherapy may have more benefit in rectal cancer
GI Cancers Symposium: Colorado study of 48 patients with locally advanced rectal cancer receiving neoadjuvant chemotherapy, found that patients receiving lower-than-recommended doses in fact saw their tumors shrink more than patients receiving the full dose.

Male fertility after chemotherapy: New questions raised
Professor Delb├Ęs, who specializes in reproductive toxicology, conducted a pilot study in collaboration with oncologists and fertility specialists from the McGill University Health Centre (MUHC) on a cohort of 13 patients, all survivors of pediatric leukemia and lymphoma.

'Combo' nanoplatforms for chemotherapy
In a paper to be published in the forthcoming issue in NANO, researchers from Harbin Institute of Technology, China have systematically discussed the recent progresses, current challenges and future perspectives of smart graphene-based nanoplatforms for synergistic tumor therapy and bio-imaging.

Nanotechnology improves chemotherapy delivery
Michigan State University scientists have invented a new way to monitor chemotherapy concentrations, which is more effective in keeping patients' treatments within the crucial therapeutic window.

Novel anti-cancer nanomedicine for efficient chemotherapy
Researchers have developed a new anti-cancer nanomedicine for targeted cancer chemotherapy.

Ending needless chemotherapy for breast cancer
A diagnostic test developed at The University of Queensland might soon determine if a breast cancer patient requires chemotherapy or would receive no benefit from this gruelling treatment.

A homing beacon for chemotherapy drugs
Killing tumor cells while sparing their normal counterparts is a central challenge of cancer chemotherapy.

Read More: Chemotherapy News and Chemotherapy Current Events is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to