Industry News Archive

  • FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC

    On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

    Read FDA announcement.

    Posted 6/30/2020



  • FDA Approves Pembrolizumab for Recurrent or Metastatic cSCC

    On June 24, 2020, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

    Read the FDA announcement.

    Posted 6/24/2020



  • FDA Approves Cyramza for First-Line Treatment of Metastatic EGFR-Mutated NSCLC

    On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved ramucirumab injection, 10 mg/mL solution (Cyramza®, Eli Lilly and Company) in combination with erlotinib, for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. With this approval, cyramza has now received six FDA approvals to treat certain types of lung, liver, stomach and colorectal cancers.

    Read the press release

    Posted 6/22/2020




  • Taiho Oncology Patient Support Program

    Taiho Oncology Patient Support offers personalized services to give patients, caregivers, and healthcare professionals the help they need in getting started with Taiho Oncology Products. This includes insurance verification, help with medication costs, and treatment plan support.

    Learn more

    Posted 6/22/2020



  • Lonsurf Efficacy Flashcard

    Lonsurf®  (FTD/TPI, Taiho Oncology) is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.


    Read efficacy and safety information

    Posted 6/22/2020



  • FDA Approves Tabrecta for Metastatic NSCLC with METex14

    On May 6, 2020, Novartis announced that the U.S. Food and Drug Administration (FDA) approved TabrectaTM (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

    Read corporate press release

    Posted 6/22/2020



  • Pfizer Oncology Personalized Support

    At Pfizer Oncology Together, patient support is at the core of everything they do. From helping to identify financial assistance options to connecting patients to resources for emotional support, the needs of patients prescribed Pfizer Oncology medications are a top priority.

    Pfizer Oncology Field Reimbursement Managers (FRMs) can help address challenging or urgent Pfizer Oncology patient access cases. Click here for the FRM contact in Virginia. 

    Posted 6/22/2020



  • FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

    On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.

    Read the FDA announcement.

    Posted 6/17/2020



  • FDA Extends Indication of Gemtuzumab Ozogamicin to CD33-Positive AML Pediatric Patients

    On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.

    Read FDA announcement.

    Posted 6/16/2020



  • FDA Approves HPV Vaccine Gardasil 9 for Prevention of Certain Head & Neck Cancers

    On June 12, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

    Read the corporate press release.

    Posted 6/15/2020




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