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BMS will file for earlier-line use of Breyanzi in lymphoma after trial win

pharmaphorum

Now, results from the ongoing TRANSFORM study show that Breyanzi was more effective than the standard second-line treatment – salvage therapy followed by high-dose chemotherapy and a stem cell transplant – at fending off disease recurrence.

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ASH: Trial backs Gilead’s Yescarta CAR-T in first-line lymphoma

pharmaphorum

The 40-patient open-label study is the first to evaluate CAR-T therapy in treatment-naïve in high-risk LBCL, which is currently treated first-line mainly with rituximab and a chemo regimen known as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). billion. .

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ADC shrinks brain metastases in HER2+ breast cancer patients

European Pharmaceutical Review

The prospective, open-label, single-arm, Phase II TUXEDO-1 study enrolled 14 women and one man with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and newly diagnosed untreated brain metastases or brain metastases progressing after previous local therapy.

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PARP rivals close in on AZ and Merck’s market leading Lynparza

pharmaphorum

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster.

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Y-mAbs claims FDA OK for neuroblastoma drug Danyelza

pharmaphorum

Danyelza has been granted accelerated approval by the FDA on the strength of two open-label phase 2 studies. And combination trials with chemotherapy are also planned. Progression-free survival and overall survival are secondary endpoints in long-term follow-up, with the data not yet available.

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FDA clears new first-line use for Servier’s Tibsovo in AML

pharmaphorum

The US regulator has approved Tibsovo (ivosidenib) in combination with Bristol-Myers Squibb’s chemotherapy Vidaza (azacitidine) as a first-line therapy for IDH1-mutated acute myeloid leukaemia (AML), expanding the eligible patient population for the drug. for the Tibsovo arm and 14.9% for the control group.

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Clovis warns of insolvency as Rubraca goes into reverse

pharmaphorum

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9