Amgen’s game-changing lung cancer treatment gains FDA approval
Thousand Oaks-based Amgen has received approval from the U.S. Food and Drug Administration for its treatment, Imdelltra, which is used on adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Announced May 16, Amgen said in a press release that Imdelltra has received accelerated approval based on “encouraging response rate and duration of response (DoR) observed in clinical studies.”
Small cell lung cancer is one of the most aggressive and devastating solid tumor malignancies.
The median survival of those diagnosed following initial therapy is approximately 12 months with just a 3% five-year relative survival rate for those with extensive stage small cell lung cancer.
According to Yale Medicine, small cell lung cancer is less common than the other type of lung cancer, non-small cell lung cancer and is far more aggressive and rapidly spreads throughout the body.
Small cell lung cancer accounts for about 15% of all lung cancer diagnoses in the United States each year, according to Yale Medicine.
The treatment is meant to be used by patients who have exhausted all other options to treat this debilitating disease, and who have a life expectancy of just four to five months.
According to Amgen’s Phase 2 trial, Imdelltra, given to patients with small cell lung cancer who had failed two or more prior lines of treatment and received 10 mg every two weeks dosing regimen, found that the patient’s life expectancy rose to a median survival of 14 months with 40% of the patients responding to the therapy.
“The FDA’s approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” Jay Bradner, executive vice president, of research and development and chief scientific officer at Amgen, said in a press release.
“This approval further demonstrates our commitment to addressing aggressive cancers through our second FDA-approved Bispecific T-cell Engager (BiTE®) molecule. Imdelltra offers these patients who are in urgent need of new innovative therapies hope, and we’re proud to deliver this long-awaited effective treatment to them.”
Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer, said in the same press release that after decades of minimal advancement in the treatment of small cell lung cancer, “there is now an effective and innovative treatment option available.”
“Today’s FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease,” Ambrose said.
Aside from being a breakthrough treatment for patients, it also has the potential to be a blockbuster for Amgen.
“Given the limited options for patients with ES-SCLC, these results represent a meaningful improvement over current options, and there is no approved standard of care in third-line SCLC, for which Amgen estimates a U.S. prevalence of 2,000 to 3,500 patients,” Matt Phipps, an analyst at William Blair, wrote to clients.’
Moreover, a William Blair note projects Imdelltra sales could reach $842 million in 2028.
According to Fierce Pharma, the U.S. price for Imdelltra is $31,500 for the first cycle, and $30,000 for subsequent cycles.
Trial patients were on the treatment for a median of over five months, which would equate to a commercial price of about $166,500.
Since the company’s announcement Barclays analyst Carter Gould upgraded Amgen’s stock to a hold with a $300 price target, citing cautious excitement around Imdelltra as it has potential, but regulation hurdles as well as competition could make the road to success longer.
Also, analysts from Mizuho Securities maintained a Hold rating on the stock with a $235 price target, although that report came a few days before the Imdelltra announcement.
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