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    • AstraZeneca leukemia...

    AstraZeneca leukemia drug Calquence gets USFDA okay

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-11-24T10:00:43+05:30  |  Updated On 13 Aug 2021 9:27 AM GMT

    New Delhi: AstraZeneca said late on Thursday that the U.S. Food and Drug Administration (FDA) had given its go-ahead for the company's Calquence drug to treat chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults.


    The drug was approved under a new speedy review program in collaboration with drug watchdogs in Canada and Australia and was also approved to treat small lymphocytic lymphoma, a similar disease.


    That will pit the AstraZeneca drug against AbbVie and Johnson & Johnson's (JNJ.N) established CLL treatment Imbruvica.


    The FDA's green light, which analysts at brokerage Bryan Garnier said came at record speed, adds momentum to Astra's growing cancer drug business with brands including Tagrisso and Imfinzi.


    "Physicians are used to Imbruvica and we do not expect a rapid and massive shift towards Calquence but we do see it progressively taking market share from the leader," Bryan Garnier analysts said, adding that FDA tests had showed Calquence performed well in terms of side effects.


    Also Read: AstraZeneca CKD anaemia drug Roxadustat shows increased haemoglobin levels in Phase 3 trial


    Astra shares were up 2.1% at 1415 GMT, outperforming a 0.7% gain in the STOXX Europe 600 Health Care. SXDP index.


    Astra shares have risen 28% this year, boosted by revenue growth from new drugs.





    Average analyst forecasts point to 2024 Calquence sales of almost $1.5 billion, up from a projected $160 million this year, according to Refinitiv data.


    Abbvie and J&J chalked up 2018 Imbruvica revenues of $3.6 billion and $2.6 billion, respectively.


    Calquence had previously been approved for the relatively smaller group of mantle cell lymphoma (MCL) patients that had received prior therapy.


    Also Read: Sun Pharma signs licensing pact with AstraZeneca to introduce Novel Oncology products in China




    AbbVie AstraZeneca Calquence cancer Chronic lymphocytic leukemia Imbruvica Imfinzi JnJ Johnson and Johnson leukemia drug Tagrisso USFDA USFDA approved 
    Source : Reuters

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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