Go or no go? Immunomedics, Exelixis and Alkermes await FDA letters

Shutdown or no, drug reviews are still under way, giving the sector something to look forward to as 2019 kicks off.

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The US government’s shutdown over a budget dispute has put the brakes on new US FDA submissions, but drug reviews funded by user fees will continue. This could be good news for companies including Immunomedics, which is approaching a decision deadline for its antibody-drug conjugate sacituzumab govitecan.

Joining Immunomedics in the January oncology decision queue is Exelixis, which is expecting Cabometyx to get a mid-month go-ahead in a new use, hepatocellular carcinoma. And after rough treatment at an advisory committee meeting, Alkermes might be holding out hope, however unlikely, that FDA staff will ignore the advice of expert advisors and approve its depression project ALKS 5461.

Positive on triple negative

Immunomedics is hoping for approval in the tough indication of third-line metastatic triple-negative breast cancer. The filing is based on phase I/II data presented at Asco, in which the agent achieved a 31% remission rate and a 7.4-month median duration of response. The agency’s generally friendly view of oncology projects, particularly in populations with few options, could bode well for sacituzumab govitecan's chances.

Notable January and early February first time approvals
Product Company  PDUFA date Product NPV ($m)
Sacituzumab govitecan Immunomedics Jan 18 n/a
ALKS 5461 Alkermes Jan 31 383
Cablivi Sanofi Feb 6 2,387

On the other hand, Alkermes is likely to get a thumbs-down after a disastrous adcom for ALKS 5461. The panel voted 20-3 against the project on efficacy based on an FDA staff analysis challenging the validity of studies that the company claimed were positive and questioning whether Alkermes' study designs were robust enough to support approval (Alkermes gets decisive thumbs down, November 2, 2018).

An early February decision that could creep into January concerns Sanofi’s Cablivi (caplacizumab) in the rare condition thrombotic thrombocytopaenic purpura. The French pharma needs a positive decision to help justify its €3.9bn ($4.4bn) acquisition of Ablynx.

Expanding indications

Being an Exelixis investor takes steady nerves as the California-based group is frequently buffeted by competitive threats – most recently, news that Pfizer and Merck KGaA were first out of the gates with phase III data on a PD-1/kinase inhibitor combination in first-line renal cell carcinoma, ahead of Exelixis’s work with both Bristol-Myers Squibb and Roche (Pincer movement squeezes Exelixis in kidney cancer, September 12, 2018).

Therefore a win for Cabometyx in previously treated hepatocellular carcinoma would be a comfort for Exelixis. Liver cancer is expected to add $305m to Cabometyx sales by 2024, bringing total revenues to $1.4bn, according to EvaluatePharma’s consensus of sellside analysts.

Supplementary approvals and other notable regulatory decisions for January
Product Company Event type Date
Cabometyx Exelixis sNDA/BLA for Cabometyx for previously treated advanced hepatocellular carcinoma Jan 14
Darzalex Genmab/Johnson & Johnson sBLA for split dosing regimen for Darzalex for multiple myeloma Feb 8
PF-05280014 Pfizer BSUFA on resubmission of Herceptin biosimilar for breast cancer Q1 2019

Meanwhile, Pfizer is due a decision sometime in the early part of the year on its Herceptin biosimilar, PF-05280014. Pfizer and Roche have have settled all outstanding patent litigation, presumably clearing the way for biosimilar launch soon after the Herceptin intellectual property expires around mid-year. As with many biosimilars, the molecule received a first-cycle rejection from the FDA, but Pfizer will hope to be successful the second time around as the project's hoped-for launch date, likely in late 2019 or early 2020, is drawing near.

And Johnson & Johnson and Genmab are awaiting an FDA decision on Darzalex that could come early. The companies hope to get the go-ahead to split the first infusion of Darzalex, which takes a minimum of six hours, over two consecutive days to make therapy more flexible. The EU's CHMP issued a positive opinion on split dosing of the drug in November.

Drug approval decisions do not appear to have been hindered by the partial government shutdown yet, and likely will proceed at a normal pace for now. But with submissions on hold until Congress and the White House can agree to a new funding package, the chances of a slowdown in approvals later this year will rise.

Last year was a bumper year for FDA approvals, and it would be unfortunate for the sector if the current pace were to be substantially disrupted.

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