GSK blood cancer drug pulled from US market in major blow
GlaxoSmithKline’s (GSK) blood cancer drug has been pulled from the US market, in a major blow to the British pharmaceutical giant’s reputation as it seeks to build out its oncology offering.
The London-listed firm announced yesterday that the US Food and Drug Administration (FDA) had requested the company to withdraw the market authorisation for the drug, known as Blenrep, over safety concerns.
The drug was announced to have missed key markers in a late-stage trial earlier this month.
“Blenrep being pulled from the US market is more of a blow to GSK’s reputation than a significant financial [one],” Sebastian Skeet, senior healthcare analyst at investment research firm Third Bridge, told Morning Wire
The drug is not “entirely dead in the water”, with two ongoing second-stage trials expecting to produce data in the coming months. However, “it does not look good” for the company given the “stiff competition” in the market, Skeet continued.
Blenrep received separate conditional approvals from both the FDA and the European Medicines Agency (EMA) in August 2020. The drug’s presence in Europe now hangs in the balance.
“Whilst Blenrep may continue to be marketed in Europe, GSK withdrawal from the US market will likely send shockwaves into Europe and impact physician prescribing habits,” he said.
Dana Gheorghe, director of oncology at pharmaceutical intelligence company Citeline added that it is “likely” the EMA will start reviewing Blenrep’s approval “sooner rather than later – unless GSK withdraw the drug from the European market beforehand”.
The treatment’s FDA label carries a black box warning for an ocular toxicity which are managed primarily by dose interruptions.
It is thought that concerns have already been weighing on Blenrep, as sales – while still in the tens of millions of dollars – have dwindled this year.
The Bottom Line
GlaxoSmithKline’s (GSK) bid to cement itself as a leader in the cancer drug market has faced a double-barrelled setback this month.
The Big Pharma firm had sought to ramp up its oncology pipeline following the split from its consumer health unit, now known as Haleon, earlier this year.
But the call to withdraw its blood cancer drug Blenrep from the US market will likely spell trouble for the treatment’s uptake across the pond in Europe.
Blenrep’s setback risks sowing the seed of doubt across the continent, likely troubling doctors within the bloc who may now be questioning their prescription habits. GSK’s ovarian cancer drug Zejula has also failed to exit the FDA’s hawkish scope unscathed.
The drug, which was approved as a maintenance therapy in 2017, was fitted with a narrower use label in the US last week.
Extremely promising results from the late-stage trial of its RSV vaccine – set to be the first of its kind – is expected to carry GSK through the anticipated choppy, regulatory, waters in the EU.
Investors have already outlined the vaccine as a key potential growth driver for the company – which explains why GSK’s share price was spared a dip into the red yesterday.
Analysts at Shore Capital Markets reiterated their ‘buy’ recommendation for GSK shares despite the blow, saying they expected the news when the company dialled back its Blenrep sales forecast from around $500m (£421m) to $150m (£126.4m) after the failure of its late-stage trial.
The worst appears to be over for GSK in terms of Blenrep’s US failure, but more pain is to come this side of the Atlantic.