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New targeted lung cancer treatment coming to UK under MHRA scheme

The MHRA has issued an Early Access to Medicines Scheme (EAMS) positive scientific opinion for tepotinib, for the treatment of adult patients with advanced Non-Small Cell Lung Cancer (NSCLC).

Tepotinib is a monotherapy developed by Merck, and the positive opinion was issued for patients with NSCLC that are harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations.

Sanofi’s NSCLC drug gains EC approval

The European Commission (EC) has approved Sanofi and Regeneron’s PD-1 inhibitor, Libtayo (cemiplimab), for the first-line treatment of adults with non-small cell lung cancer (NSCLC) whose tumor cells have ≥50% PD-L1 expression and no EGFR, ALK, or ROS1 aberrations.

Libtayo is now approved for three advanced cancers in the European Union. The EC also approved Libtayo in advanced basal cell carcinoma, the first treatment to be indicated for those patients who have progressed on or are intolerant to a hedgehog pathway inhibitor.

EMA panel recommends label extension of AstraZeneca's Imfinzi in non-small cell lung cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has backed a new dosing regimen of AstraZeneca’s Imfinzi (durvalumab) in the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC), recommending the drug be made available in the European Union in a 1,500mg fixed dose every four weeks rather than every two weeks.

The label extension only applies to NSCLC patients in whom more than 1% of their tumour cells express PD-L1 and who have seen their disease halted through platinum-based chemoradiation therapy (CRT).

Roche's Tecentriq combo scores FDA approval in non-small cell lung cancer

Roche’s immunotherapy Tecentriq (atelizumab) has chalked up another approval from the FDA, this time in combination with the chemotherapy Abraxane (paclitaxel protein-bound; nab-paclitaxel and carboplatin) for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients whose tumours display no EGFR or ALK genomic aberrations.

Phase 3 data submitted in support of the approval showed that the combo produced a median overall survival benefit of 18.6 months compared to 13.9 months with chemo alone in the intention-to-treat wild-type populati

AstraZeneca's Imfinzi triple combo beats chemo in treatment-naive metastatic lung cancer

AstraZeneca has unveiled positive new Phase 3 data for the combination of Imfinzi (durvalumab) and anti-CTLA4 antibody tremelimumab with chemotherapy in treatment-naïve metastatic non-small cell lung cancer (NSCLC), showing that the therapy met its primary endpoint in the trial.

In a study comparing the efficacy of Imfinzi plus one of five standard-of-care platinum-based chemotherapy options versus chemo alone, the aforementioned combo was shown to generate a “statistically significant and clinically meaningful improvement” in progression-free survival.

BMS' Opdivo+Yervoy+Chemo combo shows superior overall survival in first-line lung cancer

Bristol Myers Squibb has lifted the curtain on new Phase 3 data for its blockbuster immunotherapy Opdivo (nivolumab), showing that the drug, when combined with Yervoy (ipilimumab) and two cycles of chemotherapy, met its primary endpoint for the first-line treatment of advanced non-small cell lung cancer (NSCLC).

At a pre-specified analysis, the results illustrated that the combo showed superior overall survival benefit in relation to its comparator, chemotherapy monotherapy for up to four cycles followed by optional maintenance therapy.

Roche's Tecentriq combo recommended in Europe for non-small cell lung cancer

Riche’s blockbuster immunotherapy Tecentriq (atezolizumab) is closing in on securing yet another approval after it revealed that the drug was awarded a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

The recommendation covers Tecentriq’s use in combination with carboplatin and Abraxane chemotherapy in the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adult patients whose tumours are not EGFR mutant or ALK-positive.

BMS' blockbuster Opdivo flies high and falls short in non-small cell lung cancer

Bristol-Myers Squibb has pulled back the veil on new data from two analyses of its blockbuster immunotherapy Opdivo (nivolumab) in the first-line treatment of non-small cell lung cancer (NSCLC), and not all of it was positive.

In the first of two announcements, it was revealed that, in part 1a of a Phase 3 trial, Opdivo in combination with low-dose Yervoy (ipilimumab) outmatched chemotherapy in improving overall survival (OS) in first-line NSCLC patients whose tumours expressed PD-L1 ≥1%, meeting the trial’s co-primary endpoint.

Pfizer scores conditional European approval in ALK-positive lung cancer with Lorviqua

Pfizer’s Lorviqua (lorlatinib), or Lorbrena as it is known in the US, Canada and Japan, has just been awarded conditional marketing approval from the European Commission (EC) for the treatment of anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), according to the company.

Specifically, the drug has been approved as a monotherapy for adult patients whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.

MSD's Keytruda/chemo combo nabs EU approval in first-line metastatic squamous lung cancer

MSD’s anti-PD-L1 therapy Keytruda (pembrolizumab) has been awarded marketing authorisation in Europe for the first-line treatment of adult patients with metastatic squamous non-small cell lung cancer (NSCLC) when used in combination with carboplatin and either paclitaxel or nab-paclitaxel, it has emerged.

Phase 3 data submitted in support of the application illustrated that the combo “significantly improved overall survival (OS)”, reducing risk of death by 36% compared to chemotherapy alone regardless of a patient’s PD-L1 tumour expression status.

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