Cancer

The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.

Launching In Vivo’s oncology therapeutic review series, this first instalment provides a data-led primer on the global cancer landscape. Future instalments will explore market dynamics, pipeline evolution and the innovations set to define oncology therapeutics through 2032.

Dizal's Zegfrovy (sunvozertinib), already approved in the US and China for the second-line treatment of NSCLC with EGFR exon 20 insertion mutations, triumphs in the WU-KONG28 Phase III study in the first-line setting.

Scrip spoke with Debiopharm’s Luke Piggott about the Swiss biotech’s interest in synthetic lethality and strategy around development and partnering.

The drugmaker announced that its Phase II trial of atirmociclib, a CDK4 inhibitor, succeeded in patients who had progressed on CDK4/6 inhibitors and had better tolerability than the earlier class.

Cipla has agreed to delay US launch of its sodium thiosulfate generic until 2033 – albeit six years before patent expiry – resolving multi-patent litigation with Fennec while leaving key commercial terms undisclosed.

Novartis’s ianalumab, for treating Sjögren’s disease, is also among the new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

The company announced Phase I data for varsetatug masetecan in metastatic colorectal cancer, where it sees a significant and largely untapped market.

The biotech stopped a Phase III trial combining Merck’s Keytruda with eftilagimod alfa in first-line non-small cell lung cancer due to futility.

Genentech has asked the US International Trade Commission to investigate Biocon and related entities over alleged infringement tied to pertuzumab biosimilars, seeking remedies that could block imports into the US.

Clinical Data Readout: Jacobio Pharmaceuticals and AstraZeneca's JAB-23E73, a pan-KRAS inhibitor, stands out among its peers as the first to report preliminary Phase I results after completing the dose escalation phase of a China-based clinical study.

The CELMoD combined with Kyprolis/dexamethasone showed superior PFS, bringing another combination to the second-line disease setting.