Over the last few days, the US Food and Drug Administration (FDA) has granted approval to several oncology products across both the pharmacological, imaging and companion diagnostic (CDx) realms – offering patients new treatment options with outcome-altering potential.
This includes AstraZeneca’s AKT inhibitor, Truqap (capivasertib), which secured US regulatory approval alongside Zytiga (abiraterone) and androgen deprivation therapy (ADT) in adults with PTEN-deficient, metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer – making it the first targeted therapy to achieve this milestone.
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Truqap obtained an approval in mAPMN/S, previously called metastatic hormone-sensitive prostate cancer (mHSPC), based on the outcomes of the Phase III CAPItello-281 trial (NCT04493853). During the study, a combination of Truqap, Zytiga and ADT triggered a significant 19% drop in the risk of radiographic disease progression or death versus Zytiga plus ADT alone, while extending median radiographic progression-free survival by 7.5 months.
Truqap’s landmark US approval comes as treatment options for PTEN-deficient patients with mAPMN/S remain sparse, and outcomes remain poor due to faster disease progression and a generally poor prognosis. Currently, researchers estimate that around a quarter of patients with mHSPC have PTEN-deficient tumours.
According to Daniel George, CAPItello-281 investigator and director of genitourinary oncology at Duke Cancer Institute, encouraging and maintaining remission in patients with mAPMN/S is a “high priority”, so Truqap’s approval represents a “significant clinical advance with the potential to improve [patient] lives and change the course of disease”.
To allow for wider-scale access to Truqap, AstraZeneca has also filed an application for the drug in mAPMN/S with European regulators, which is currently under review. The drug is currently greenlit for use in adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with specific gene alterations (PIK3CA, AKT1, or PTEN), provided they have progressed on at least one endocrine therapy-based regimen.
Roche’s PTEN CDx gets the FDA’s blessing
In another win for PTEN-deficient patients with prostate cancer, Roche’s VENTANA PTEN (SP218) RxDx qualitative diagnostic assay has become the first CDx of its kind to get the FDA stamp of approval.
Greenlit alongside Truqap, VENTANA PTEN (SP218) RxDx is indicated for use as a pre-treatment test for adults with prostate adenocarcinoma, which determines their eligibility for treatment with the targeted therapy by revealing if a patient is PTEN-deficient.
Like Truqap, VENTANA PTEN (SP218) RxDx got the FDA’s blessing based on the results of the CAPItello-281 trial, where the CDx was used as an enrolment assay to identify PTEN-deficient patients eligible for treatment.
This comes as companion diagnostics become increasingly implemented across the oncology landscape, as treatment approaches become more personalised and targeted to a patient’s tumour profile and genetics.
Bayer’s low-dose MRI contrast agent gets the US go-ahead
Alongside decisions around pharmaceutical and CDx products, the FDA has also granted approval to Bayer’s radiological MRI contrast agent, Ambelvist (gadoquatrane) in adult, paediatric and term neonates for the detection of abnormal or damaged tissue with atypical vascularity.
This means US clinicians can now use Ambelvist to monitor disease progression and inform treatment decisions in various diseases of the central nervous system (CNS) and the wider body – including cancers and neurological conditions like multiple sclerosis (MS).
The FDA cleared Ambelvist based on results of the global Phase III QUANTI programme, which looked at the efficacy and safety of the macrocyclic gadolinium (Gd)-based contrast agent in patients undergoing contrast-enhanced MRI. During the series of studies, Ambelvist boosted lesion visualisation at a decreased dose of Gd, while proving safe in both adult and paediatric patients undergoing an MRI.
Following Ambelvist’s approval, the Gd-containing contrast agent has become the lowest-dosed imaging option of its kind to get the FDA’s blessing, which Jill Carbone, Bayer’s VP and Head of Radiology, North America Product & Pipeline, says will “support healthcare providers in adhering to growing clinical guidance to utilise the lowest Gd dose necessary to adequately image patients”.
The imaging agent is associated with a boxed warning, however, which details Ambelvist’s associated risks linked to intrathecal administration and a condition called nephrogenic systemic fibrosis, which generally occurs in individuals with impaired kidney function.
MSD widens Keytruda’s reach with Welireg combo approval
Alongside Truqap’s approval, MSD has once again strengthened the legacy of its mega-blockbuster cancer therapy, Keytruda (pembrolizumab) by securing the US regulatory greenlight for the drug alongside its hypoxia-inducible factor 2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), as an adjuvant combination for the treatment of intermediate-high or high-risk renal cell carcinoma with a clear cell component (ccRCC) post-kidney resection.
This comes as Keytruda’s patent expiry looms, with its first market exclusivity protections expected to expire in 2028.
