In This Article:
This week, the European Commission granted marketing authorization to the expanded use of AbbVie’s ABBV Rinvoq and AstraZeneca’s AZN blockbuster cancer drugs, Imfinzi and Daiichi-Sankyo partnered, Enhertu. Novartis NVS announced plans to invest $23 billion over the next five years to boost manufacturing, R&D and technology in the United States amid the tariff threats.
Here's a recap of the week’s most important stories.
European Commission Approves AbbVie’s Rinvoq for 8th Indication
The European Commission (“EC”) granted marketing approval to AbbVie’s Rinvoq for treating giant cell arteritis (“GCA”), an autoimmune disease that causes inflammation of the large arteries. Rinvoq is the first JAK inhibitor approved in the European Union (“EU”) for this indication, based on data from the phase III SELECT-GCA study. An application seeking approval of Rinvoq for GCA is also under review in the United States.
GCA marks the eighth approved indication for Rinvoq, which is already approved for seven immune-mediated inflammatory diseases in several countries, including the United States and the EU. It is being studied in late-stage studies for some others like systemic lupus erythematosus, hidradenitis suppurativa vitiligo and Takayasu arteritis.
EU Approval for the Expanded Use of AZN’s Key Cancer Drugs
AstraZeneca announced that the EC has approved the expanded use of Imfinzi in combination with chemotherapy for treating adults with resectable non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements. In this regimen, Imfinzi, in combination with neoadjuvant chemotherapy, is administered before surgery and as adjuvant monotherapy after surgery.
The approval in the EU was expected as the Committee for Medicinal Products for Human Use had recommended the approval of Imfinzi for the given indication last month. This approval was based on data from the phase III AEGEAN study. Imfinzi was approved for a similar indication in the United States in August last year.
The EC also approved the expanded use of AstraZeneca and partner Daiichi Sankyo’s Enhertu in breast cancer. The regulatory body has now approved Enhertu as a monotherapy for treating metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for endocrine therapy as the next line of treatment in the EU.
The latest nod in the EU expands the approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow. The latest approval is based on data from the DESTINY-Breast06 study. Enhertu was approved for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer in the United States in January.