Royalty Pharma inks US$ 2 bn cancer drug deal with Revolution; Astra-Daiichi’s Datroway wins US approval for lung cancer

By PharmaCompass

2025-06-26

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In news this week, Royalty Pharma committed up to US$ 2 billion to Revolution Medicines for their promising pancreatic and lung cancer drug daraxonrasib. The US Food and Drug Administration (FDA) granted accelerated approval to AstraZeneca and Daiichi Sankyo’s Datroway, a treatment for lung cancer.

The agency also approved Cycle Pharma’s Harliku (nitisinone) for an ultra-rare genetic disorder and Sanofi-Regeneron’s Dupixent (dupilumab) for adult patients with bullous pemphigoid, a debilitating autoimmune skin disorder.

In the mental health space, Compass Pathways’ psilocybin-based therapy COMP360 successfully met its primary endpoint in a phase 3 trial for treatment-resistant depression.

Eli Lilly’s oral GLP-1 drug orforglipron delivered compelling results in late-stage trials, positioning itself as a convenient alternative to injectable diabetes medications. Roche celebrated a significant win as their Lunsumio-Polivy combination therapy tripled progression-free survival in lymphoma patients compared to standard chemotherapy.

However, Stuart Therapeutics faced disappointment when its dry eye disease drug ST-100 failed to meet its primary endpoint in a phase 3 trial. And the US withdrew funding to Gavi, a global alliance that helps buy vaccines for the world’s poorest children. The Gates Foundation is stepping in, committing US$ 1.6 billion over five years.

Royalty Pharma inks US$ 2 bn deal with Revolution Medicines for cancer drug

Royalty Pharma and Revolution Medicines have struck an agreement, wherein Royalty will provide up to US$ 2 billion to fuel the development and commercialization of daraxonrasib, a promising med that targets pancreatic ductal adenocarcinoma and non-small cell lung cancer (NSCLC).

Under the terms, Royalty Pharma has committed up to US$ 1.25 billion in ‘synthetic royalty financing’, releasing an initial US$ 250 million immediately, with future payments tied to milestones such as positive phase 3 data and an FDA approval. Synthetic royalty financing allows companies to raise capital by selling a part of their future revenues, while retaining ownership of an asset. The deal also includes US$ 750 million in secured debt.

Astra-Daiichi’s ADC Datroway wins US approval for lung cancer

FDA has granted accelerated approval to Datroway (datopotamab deruxtecan), a precision cancer therapy developed by AstraZeneca and Daiichi Sankyo, for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC who have previously received EGFR-directed therapy and platinum-based chemotherapy. This marks the first US approval of a TROP2-directed antibody-drug conjugate (ADC) for lung cancer.

Datroway is an ADC that targets the TROP2 protein, which is over-expressed in various cancers, including NSCLC. By delivering cytotoxic agents directly to cancer cells, it aims to minimize damage to healthy tissues.

FDA had previously approved Datroway for the treatment of certain forms of breast cancer, making this its second US approval in less than six months.

FDA okays Cycle Pharma’s med for ultra-rare genetic disorder: FDA has approved Cycle Pharmaceuticals’ Harliku (nitisinone), the first and only treatment for alkaptonuria (AKU), a debilitating ultra-rare genetic disorder. AKU causes harmful build-up of homogentisic acid, resulting in tissue pigmentation, arthritis, and potentially serious cardiac and renal complications.

Dupixent okayed for rare skin disease: FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) for adult patients with bullous pemphigoid, marking the first and only targeted biologic treatment for this debilitating autoimmune skin disorder. This is the eighth FDA approval granted to Dupixent.

Compass Pathways’ depression therapy reduces severity of symptoms in study

Compass Pathways has announced that its investigational psilocybin-based therapy, COMP360, has achieved the primary endpoint in its first phase 3 trial (COMP005) for treatment-resistant depression (TRD). The study demonstrated that a single 25 mg dose of COMP360 led to a statistically significant and clinically meaningful reduction in depressive symptoms, compared to placebo at six weeks, as measured by the Montgomery–Åsberg Depression Rating Scale (MADRS). This is the first time a synthetic psilocybin has shown efficacy in a phase 3 trial for TRD.

Lilly’s oral GLP-1 drug orforglipron delivers positive results in late-stage trial

Eli  Lilly’s experimental oral GLP-1 receptor agonist, orforglipron, has delivered compelling late-stage results in adults with type 2 diabetes. Over 40 weeks, the highest dose produced approximately 7.9 percent weight loss, comparable to outcomes seen with injectable semaglutide and tirzepatide.

As a non-peptide, small molecule oral pill orforglipron offers once daily dosing without food or water restrictions. It also does not require refrigeration, and may reduce production and distribution costs. Eli Lilly plans to seek regulatory approval for weight management by the end of 2025 and for type 2 diabetes in 2026.

Meanwhile, its investigational antibody, bimagrumab, has shown remarkable results in preserving muscle mass when paired with Novo Nordisk’s GLP‑1 therapy, Wegovy (semaglutide), according to mid-stage data presented at the American Diabetes Association meeting.

Roche’s Lunsumio-Polivy scores late-stage win in lymphoma trial

Roche has unveiled positive results from a pivotal late-stage trial evaluating subcutaneous Lunsumio (mosunetuzumab) plus intravenous Polivy (polatuzumab vedotin) in transplant-ineligible patients with relapsed or refractory large B-cell lymphoma (LBCL). The regimen produced a median progression-free survival (PFS) of 11.5 months, triple that of the chemotherapy arm.

Stuart Therapeutics’ dry eye disease drug fails late-stage tear test

Stuart Therapeutics’ phase 3 trial of ST-100 (vezocolmitide) has failed to show a statistically significant improvement in tear production. The trial was assessing whether the drug could truly enhance tear volume in dry eye disease. Stuart plans to launch another study and intends to engage with the FDA to confirm the design of this additional trial, and the regulatory path to the approval of ST-100.

US stops funding to GAVI; Gates steps in to provide US$ 1.6 bn over five years

The US is withdrawing funding to Gavi, a global alliance that helps buy vaccines for the world’s poorest children. Health Secretary Robert F. Kennedy Jr said Gavi had ignored the science in immunizing children across the world. He also said that the US “will not deliver on a US$ 1.2 billion pledge made by the Biden administration until the organization changed its processes,” New York Times reported. According to RFK Jr, America has provided US$ 8 billion in funding to Gavi since 2001.

Meanwhile, the Gates Foundation said it will commit US$ 1.6 billion over the next five years to support Gavi. The vaccine alliance is looking to raise US$ 9 billion for its work from 2026 to 2030.

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