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CAR-T

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New study reveals discrepancies in FDA accelerated approval process for cancer drugs

The study looked at 46 different cancer drugs that received accelerated approvals between 2013 and 2017

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BMS and 2seventy’s multiple myeloma therapy Abecma receives expanded FDA approval

More than 35,700 new cases of the disease are expected to be diagnosed in the US this year

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J&J and Legend’s Carvykti approved by FDA for expanded multiple myeloma use

The cell therapy is the first and only BCMA-targeted therapy to be approved for this condition as early as first relapse

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AstraZeneca/Daiichi Sankyo’s Enhertu granted FDA accelerated approval for solid tumours

The ADC has been authorised to treat adults with unresectable or metastatic HER2-positive tumours

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AstraZeneca’s Voydeya granted FDA approval for rare blood disease PNH

Up to 20% of patients treated with C5 inhibitors experience clinically significant extravascular haemolysis

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FDA grants Invivyd’s Pemgarda emergency use authorisation for COVID-19 prevention

The long-acting monoclonal antibody is authorised for use in adults and adolescents

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Merck’s Winrevair granted FDA approval to treat pulmonary arterial hypertension in adults

The rare blood vessel disorder affects approximately 500 to 1,000 people in the US every year

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AstraZeneca’s Ultomiris receives FDA approval to treat rare autoimmune disease NMOSD

Neuromyelitis optica spectrum disorder is estimated to affect approximately 6,000 adults in the US

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Johnson & Johnson’s Opsynvi granted FDA approval in pulmonary arterial hypertension

The rare form of pulmonary hypertension is responsible for up to 1,000 new cases in the US every year

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AbbVie’s Elahere granted full FDA approval for previously-treated ovarian cancer

The company recently gained access to the therapy through its $10.1bn acquisition of ImmunoGen

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FDA approves Italfarmaco’s Duvyzat as first nonsteroidal Duchenne muscular dystrophy drug

The neuromuscular genetic disease is estimated to affect one in every 3,500 to 6,000 male births worldwide

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Takeda’s Iclusig combination granted FDA accelerated approval for rare form of leukaemia

The drug is now the first targeted therapy approved as a frontline treatment for Ph-positive ALL

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