News Highlights – April 2021


April followed the trend of March, with many advances in the liquid biopsy field. At the same time, there is an increasing interest in regulating the space, as the European Commission is moving forward with its appraisal of the impact of Grail’s acquisition by Illumina on the EU market.

On the diagnostic side, France has started changes in its testing funding system, with the inclusion of BCR-ABL into the formal reimbursement list, the first molecular biomarker that transitioned from the innovation fund into the statutory insurance system. Further advancements in diagnostics include Guardant Health agreement with Daiichi Sankyo to provide Guardant360 as the CDx for the treatment of NSCLC patients with trastuzumab-deruxtecan, and the Illumina partnership with Kartos Therapeutics to develop an NGS-based TP53 CDx.

As for the regulatory outcomes in April, nivolumab (BMS) got approval for renal cell carcinoma in combination with cabozantinib (EMA), for gastric and oesophageal cancers in combination with chemotherapy (FDA), and received a positive CHMP opinion recommending approval for malignant pleural mesothelioma. While nivolumab has made the news with multiple trials, including a combination with Candel’s CAN-2409 (oncolytic viral immunotherapy) for advanced gliomas, it also saw the rejection of NICE for the combo nivo+ipi for first line NSCLC based on cost-effectiveness.

In addition, both EMA and FDA approved GSK’s dostarlimab for the treatment of advanced or recurrent endometrial cancer, with Roche’s Ventana MMR RxDx immunohistochemistry panel as its CDx (FDA).
Summary of news (with links)


Regulatory decisions on Rx (18)



Dx approvals, market access and reimbursement (3)



Latest diagnostic developments, investment and CDx deals (12)



Clinical trials and drug development (16)



Observational studies (7)



Merge and acquisitions (9)



Partnerships (22)



 Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors