Remove 2021 Remove Chemotherapy Remove Labelling
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Immunocore claims first-ever FDA approval for TCR cancer therapy

pharmaphorum

At the moment the only other BiTE to reach the US market is Amgen’s CD19-targeting Blincyto (blinatumomab), which has been approved for various types of leukaemia and made $340 million in sales in the first nine months of 2021.

FDA 124
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Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

pharmaphorum

In the study, Enhertu was given to patients with HER2-low, unresectable and/or metastatic breast cancer previously treated with one to two prior lines of chemotherapy.

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BMS sets up Roche, Pfizer rivalry with Turning Point takeover

pharmaphorum

Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021. billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

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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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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.

FDA 105
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BMS finally gets FDA OK for liso-cel, sets $410k launch price

pharmaphorum

— Bristol Myers Squibb (@bmsnews) February 5, 2021. Breyanzi has however been cleared with a similar black box warning on its label for neurotoxicity and cytokine release syndrome (CRS) as Novartis and Gilead/Kite’s therapies. Our first #CARTcelltherapy is now approved by the #FDA.

FDA 111
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Phase 3 trial confirms Lumakras role in lung cancer

pharmaphorum

The 345-subject CodeBreaK 200 trial of once-daily Lumakras (sotorasib) met its primary objective of improving progression-free survival (PFS) compared to chemotherapy with intravenous docetaxel in KRAS G12C-mutated NSCLC patients previously treated with platinum-based doublet chemotherapy and checkpoint inhibitor therapy.