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Introduction to Cancer: Focus on Solid Tumors

Merck seeks new Keytruda indication in US

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Merck is seeking FDA approval for its successful melanoma drug Keytruda to be used treating lung cancer.

The Supplemental Biologics License Application (sBLA) is for the use of Keytruda (pembrolizumab) – an anti-PD1 (programmed death 1) therapy – in advanced non-small cell lung cancer (NSCLC). The drug previously received breakthrough therapy designation for this area in October last year.

Priority review for Pfizer’s lung drug

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The US Food and Drug Administration FDA has accepted Pfizer’s lung drug Rapamune for priority review.

Rapamune (sirolimus) prevents organ rejection after a kidney transplant and if given the greenlight, will be used for the treatment of rare lung disease lymphangioleiomyomatosis (LAM) in women of childbearing age.

FDA fast-tracks Roche lung cancer drug

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Roche will be celebrating after its investigational cancer drug MPDL3280A has been fast-tracked by the FDA for the second time.

The immunotherapy was given an FDA breakthrough designation status last year in the bladder cancer setting, but has now scored in non-small cell lung cancer (NSCLC).

“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,’’ says Sandra Horning who is Roche’s chief medical officer and head of products. 

Top four cancer killer rates ‘fall by a third’

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Death rates for breast, bowel, lung and prostate cancer combined have fallen by almost a third in the last 20 years according to the new figures from Cancer Research UK.

Death rates for breast cancer have fallen by 38%, bowel cancer by 34%, lung cancer by 27% and prostate cancer by 21 per cent.

CRUK, a public/pharma funded charity that conducts some R&D in the area, says that the figures during this period “highlight how research has had a powerful impact in beating cancer”.

InterMune drops EMA lawsuit over data release

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InterMune filed an injunction against the EMA for allowing third party access to Esbriet

InterMune has ended a year-long legal spat with the European Medicines Agency over the potential release of data for its lung drug Esbriet.

The specialist firm had last year filed an injunction against the EU drugs regulator from allowing third party access to its biggest earner. 

EMA accepts Boehringer IPF drug

Boehringer Ingelheim has moved a step closer to getting its investigational treatment nintedanib approved in Europe for a potentially fatal lung disease.

The European Medicines Agency has accepted nintedanib (also known as Inpulsis) for accelerated review in idiopathic pulmonary fibrosis (IPF).

In the US, the Food and Drug Administration has already given nintedanib orphan designation which increases its patent life, and analysts are predicting blockbuster sales for the drug.  

FDA approves Zykadia for late-stage lung cancer

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Novartis’ ‘breakthrough’ drug Zykadia has been approved by the FDA to treat lung cancer patients with a particular genetic mutation.

The US regulator allowed Zykadia (ceritinib) to be approved under an accelerated programme, which has seen the drug hit the market four months quicker than originally expected.

Zykadia now has a US licence for patients with late-stage (metastatic) non-small cell lung cancer (NSCLC) who over-express a certain genetic mutation, known as anaplastic lymphoma kinase (ALK).

Cancer Research funding to be doubled

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£20 million a year will be put into research leading to earlier diagnosis

Cancer Research UK is to increase its research funding by 50% over the next decade as part of a new strategy to tackle the disease across several fronts, including prevention, improving early diagnosis and finding treatments for cancers with an unmet need.

“There is an overriding belief that the next several years can, and will, transform the outlook for cancer patients,” says Harpal Kumar, the charity’s chief executive.

InterMune scores in lung trial

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InterMune has taken another step on its lengthy road to get the US regulator to approve its drug Esbriet for idiopathic pulmonary fibrosis (IPF) with positive top-line results from a new Phase III trial.

Three years ago, Esbriet (pirfenidone) was the first ever treatment for the potentially fatal lung disease to be approved in Europe.

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