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ASCO 2019 lung cancer NSCLC ASCO19 SCLC mesothelioma KEYNOTE-189 KEYNOTE-001 IMpower150 MYSTIC LCMC3 Lung-MAP S1400G S1400I Flaura CALGB 30901 DETERRED COMPASS

ASCO 2019 Lung Cancer: 36 Oral Presentations of the ASCO19 lung cancer track summarised

Non-small cell lung cancer (NSCLC) was a key feature of the American Society of Clinical Oncology (ASCO) 2019 annual meeting. This year, exciting results with neoadjuvant immunotherapy (I-O) from the LCMC3, NEOSTAR, and GECP16/03_NADIM studies as well as combinations of I-O  and PARP-inhibitors with chemoradiation therapy, and more. A summary of 36 oral presentations on NSCLC, SCLC, and Mesothelioma.

ASCO 2019 lung cancer NSCLC ASCO19 SCLC mesothelioma KEYNOTE-189 KEYNOTE-001 IMpower150 MYSTIC LCMC3 Lung-MAP S1400G S1400I Flaura CALGB 30901 DETERRED COMPASS
FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

Filgrastim-aafi FDA approved as Filgrastim Biosimilar

On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.

FDA approved enzalutamide (XTANDI, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC). More Information.  July 13, 2018

FDA approved biosimilar pegfilgrastim to decrease the chance of febrile neutropenia in patients with non-myeloid cancers on myelosuppressive chemotherapy

 

  • FDA approved Fulphila (pegfilgrastim-jmdb, Mylan GmbH), a biosimilar of Neulasta (pegfilgrastim, Amgen, Inc.) to decrease the chance of infection due to febrile neutropenia in patients receiving myelosuppressive chemotherapy with clinically significant incidence of febrile neutropenia and with non-myeloid cancers.
Ribociclib FDA label updated to include pre- and perimenopausal women

Biosimilar epoetin alfa-epbx approved by FDA for the treatment of anemia due to chronic kidney disease, use of zidovudine for HIV, and concomitant myelosuppressive chemotherapy

 

  • On May 14, 2018 the FDA announced approval of biosimilar epoetin alfa-epbx (Retacrit®, Hospira, a subsidiary of Pfizer) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. Epoetin alfa-epbx is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery. Retacrit® is a biosimilar of Epogen/Procrit (epoetin alfa, Amgen).
Ribociclib FDA label updated to include pre- and perimenopausal women
US FDA approved CAR-t cell BiTE DAR-T cell CD19 Immunotherapies blinatumomab axicabtagene ciloleucel tisagenlecleucel

US FDA approved CAR-T cell and BiTE immunotherapy – Updated 2-May-2018

The two CAR-T cell immunotherapies axicabtagene ciloleucel (Yescarta®) and tisagenlecleucel (Kymriah®) and the BiTE blinatumomab (Blincyto®) have in common that they target CD19 on the cancer cells. Do you know all the US FDA approved CAR-T and BiTE immunotherapies?

US FDA approved CAR-t cell BiTE DAR-T cell CD19 Immunotherapies blinatumomab axicabtagene ciloleucel tisagenlecleucel

FDA granted accelerated approval to blinatumomab for the treatment of adult and paediatric patients with B-cell precursor ALL in first or second complete remission with MRD ≥0.1%