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Thread: Three highly anticipated drugs in the pipeline

  1. #1

    Three highly anticipated drugs in the pipeline

    Market research firm EvaluatePharma evaluated all of the experimental cancer drugs in late-stage development. The firm ranked these drugs by projected worldwide sales five years from now -- assuming the drugs win regulatory approval. Eli Lilly (NYSE: LLY), Incyte (NASDAQ: INCY), and Johnson & Johnson (NYSE: JNJ) each landed a top spot in that ranking for their pipeline candidates. Here are the three most promising cancer drugs in late-stage development.

    1. Abemaciclib
    Eli Lilly could have a big winner on its hands with abemaciclib. EvaluatePharma projects the drug will generate sales of $1.8 billion by 2022, if approved. The U.S. Food and Drug Administration (FDA) granted priority review for abemaciclib in July as a treatment for advanced breast cancer, which means that an approval decision should be made in early 2018. Lilly also plans to file for regulatory approval in Europe by the end of the third quarter of 2017 and in Japan by the end of the year.

    In a late-stage study of abemaciclib in combination with AstraZeneca's (NYSE: AZN) Faslodex, breast cancer patients receiving the combo therapy achieved median progression-free survival rates of 16.4 months compared to 9.3 months for those receiving Faslodex alone. Abemaciclib also demonstrated improvement in progression-free survival rates for breast cancer patients in a late-stage study with the drug combined with either letrozole or anastrozole chemotherapies.

    2. Epacadostat
    Incyte's epacadostat could make over $1.7 billion in sales in 2022, according to EvaluatePharma's analysis. The biotech is evaluating epacadostat in eight clinical studies for treating several types of cancer, including non-small-cell lung cancer, renal cancer, head and neck cancer, and bladder cancer.

    The most advanced clinical trial, though, is a late-stage study of epacadostat in combination with Merck's Keytruda targeting treatment of melanoma. Results from this study are expected in 2018. Incyte also plans to initiate two other late-stage studies of epacadostat this year, one in combination with Keytruda and another in combination with Bristol-Myers Squibb's Opdivo.

    3. Apalutamide , ARN-509, also JNJ-56021927,
    The late-stage candidate is projected to pull in sales of $1.6 billion five years from now.

    Apalutamide is in four late-stage clinical studies targeting prostate cancer. One of those studies features a combination of the drug with J&J's already-approved prostate cancer drug Zytiga. Johnson & Johnson expects its first regulatory filing will be made by the first half of 2018, with potentially three other submissions by 2021.

  2. #2
    Super Moderator Top User po18guy's Avatar
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    Feb 2012
    Interesting news, although it seems from the investment standpoint. Nevertheless, these drugs would probably not be developed otherwise.
    07/08 Age 56 DX 1) Peripheral T-Cell Lymphoma-Not Otherwise Specified. Stage IV-B, >50 ("innumerable") tumors, bone marrow involvement.
    08/08-12/08 Four cycles CHOEP14 + four cycles GND (Cyclofosfamide, Doxorubicin, Vincristine, Etoposide, Prednisone & Gemcitabine, Navelbine, Doxil)
    02/09 2) Relapse.
    03/09-06/13 Clinical trial of Romidepsin > long-term study. NED for 64 twenty-eight day cycles, dose tapered.
    07/13 3) Relapse, 4) Suspected Mutation.
    08/13-02/14 Romidepsin increased, stopped for lack of response. Watch & Wait.
    09/14 Relapse/Progression. Visible cervical nodes appear within 4 days of being checked clear.
    10/06/14 One cycle Belinostat. Discontinued to enter second clinical trial.
    10/25/14 Clinical trial of Alisertib/Failed - Progression.
    01/12/15 Belinostat resumed/Failed - Progression. 02/23/15
    02/24/15 Pralatrexate/Failed - Progression. 04/17/15
    04/15 Genomic profiling reveals mutation into PTCL-NOS + AngioImmunoblastic T-Cell Lymphoma. Stage IV-B a second time. Two dozen tumors + small intestine (Ileum) involvement.
    04/22/15 TREC (Bendamustine, Etoposide, Carboplatin). Full response in two cycles. PET/CT both clear. Third cycle followed.
    06/15-07/15 Transplant preparation (X-rays, spinal taps, BMB, blood test, MUGA scan, lung function, CMV screening, C-Diff testing etc. etc. etc.) Intrathecal Methotrexate during spinal tap.
    BMB reveals 5) 26% blast cells of 20q Deletion Myelodysplastic Syndrome MDS), a bone marrow cancer.
    07/11-12/15 Cyclofosfamide + Fludarabine conditioning regimen.
    07/16/15 Total Body Irradiation.
    07/17/15 Moderate intensity Haploidentical Allogeneic Stem Cell Transplant receiving my son's peripheral blood stem cells.
    07/21-22/15 Triple dose Cyclofosfamide + Mesna, followed by immunosuppressants Tacrolimus and Mycophenolate Mofetil.
    07/23-08/03/15 Marrow producing zero blood cells. Fever. Hospitalized two weeks.
    08/04/15 Engraftment occurs, and blood cells are measureable - released from hospital.
    08/13/15 Day 26 - Marrow is 100% donor cells. Platelets climbing steadily, red cells follow.
    09/21/15 Acute skin Graft versus Host Disease arrives.
    DEXA scan reveals Osteoporosis.
    09/26/-11/03/15 Prednisone to control skin GvHD.
    11/2015 Acute GvHD re-classified to Chronic Graft versus Host Disease.
    05/2016 Tacrolimus stopped. Prednisone from 30-90mg daily tried. Sirolimus begun.
    09/16/16 Three skin punch biopsies.
    11/04/16 GvHD clinical trial of Ofatumumab (Arzerra) + Prednisone + Methylprednisolone begun.
    12/16 Type II Diabetes, Hypertension - both treatment-related.
    05/17 Extracorporeal Photopheresis (ECP) begun in attempt to control chronic Graft-versus-Host-Disease (cGvHD.
    05/2017 Chronic anemia (low hematocrit). Chronic kidney disease.
    06/17 Trying various antibiotics in a search for tolerable prophylaxis.
    08/17 Bone marrow biopsy reveals the presence of 2% cells with 20q Deletion Myelodysplastic Syndrome, considered to be Minimum Residual Disease.
    12/17 Bone marrow biopsy reveals no abnormalities in the marrow - MDS eradicated. The steroid taper continues.
    01/18 Consented for Kadmon clinical trial of drug KD025, a ROCK2 inhibitor that is believed to help with chronic GvHD.
    03/18 Began 400mg daily of KD025, a rho-Associated Coiled-coil Kinase 2 Inhibitor (ROCK2).
    To date: 18 chemotherapeutic drugs in 9 regimens (4 of them at least twice), 5 salvage regimens, 4 clinical trials, 4 post-transplant immuno-suppressant drugs, the equivalent of 1,000 years of background radiation from scanning from 45+ CT series scans and about 24 PET scans. Having had both lymphoid and myeloid malignancies lend a certain symmetry to the journey.

    Believing in the redemptive value of suffering makes all the difference.


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