Camizestrant

AstraZeneca must wait a little while longer for the FDA to render its decision on the oral selective oestrogen receptor degrader (SERD) camizestrant after the agency said it needed more time to review additional data.The delay — announced Wednesday — offers hope that the FDA will go against its advisory panel, which voted 6-3 last month that data from the Phase III SERENA-6 study did not support switching to camizestrant in combination with a CDK4/6 inhibitor after detection of an ESR1 mutation in circulating tumour DNA (ctDNA) prior to radiographic progression for the first-line treatment of patients with hormone receptor-positive, HER2-negative advanced disease.At the time of the negative vote, the FDA committee highlighted issues with the trial's design and how it measured progression-free survival, as well as the lack of overall survival data. AstraZeneca said Wednesday that it has since provided additional analyses requested by the agency, including ctDNA clearance data linked to longer-term efficacy outcomes — these findings will be presented on June 2 at the American Society of Clinical Oncology (ASCO) annual meeting."We look forward to continuing the dialogue with the FDA in order to bring the benefits of camizestrant with this innovative treatment strategy to eligible patients in the US as quickly as possible," said Susan Galbraith, EVP of oncology haematology R&D at AstraZeneca.Last week, the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of the camizestrant combination in this setting based on the results of SERENA-6. The drug is currently approved in the United Arab Emirates and Saudi Arabia, with regulatory applications under review in Japan and several other markets.For related analysis, see — Spotlight On: First-line and adjuvant opportunities still beckon for AstraZeneca's camizestrant despite FDA setback.

The Food and Drug Administration has delayed an approval decision on an experimental breast cancer pill its developer, AstraZeneca, views as a future blockbuster.AstraZeneca said Wednesday that U.S. regulators extended their review deadline to assess additional data provided by the company, but havent yet assigned a new date. That new information includes an analysis to be presented at the American Society of Clinical Oncology meeting on June 2 and that links the performance of the drug, known as camizestrant, to long term efficacy outcomes, the company said.We look forward to continuing the dialogue with the FDA in order to bring the benefits of camizestrant with this innovative treatment strategy to eligible patients in the U.S. as quickly as possible, said Susan Galbraith, AstraZenecas head of oncology and hematology R&D, in a statement.Camizestrant is part of a new wave of oral medicines that aim to supplant fulvestrant, a decades-old, injectable breast cancer treatment. Three of these selective estrogen receptor degraders, or SERDs, are now available for certain people with HR-positive, HER2-negative breast tumors. AstraZeneca wants to make camizestrant the fourth, and has spotlighted it as a key contributor to its plan to reach $80 billion in annual sales by 2030. Executives have predicted sales could top $5 billion per year.The outlook for oral SERDs is somewhat uncertain. All three marketed drugs are only cleared for patients with ESR1 mutations known to help tumors develop resistance, and they havent yet proven beneficial as an initial treatment. AstraZeneca, though, has claimed camizestrant touts some different characteristics than other, similar medicines. It has multiple studies underway in early lines of care.The company has been hoping camizestrant might first get to market in what would be a new kind of treatment setting. In the SERENA-6 study supporting its application, participants already on two medicines either stayed on the same regimen or swapped out one a hormone treatment for camizestrant. The group that received camizestrant had a 56% reduction in the risk of disease progression or death.Yet, on April 30, an FDA advisory committee found the evidence supporting camizestrants benefits in that setting inconclusive and requested additional data. The FDA doesnt have to follow the guidance of its expert panels, but usually does.Breast cancer experts recently polled by Leerink Partners analyst Andrew Berens have similarly critical views. In a Wednesday client note, Berens wrote that these specialists were skeptical of a U.S. approval and dont believe theres been sufficient data generated to merit the regimen's use.AstraZeneca did, however, receive an endorsement from Europes drug regulator last week. Once available there, itll be marketed under the name Etcamah. '