U.S. Food and Drug Administration

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    Helping Patients Access Investigational Treatments

    With: Lea Ann Browning-McNeeSusan C. Winckler, RPh, Esq.

    For some advanced cancer patients, the best course of action may lie beyond standard treatment options. Some of these patients can enroll in clinical trials that investigate promising new treatments. But others may find their best option is to apply for individual “expanded access” to an investigational treatment. Here, our Curious Dr. George asks two leaders from the Reagan-Udall Foundation for the Food and… Read more »

  •   Emma Shtivelman, PhD

    Excerpt:

    “On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer.

    Approval was based on the IMpower133 study, a randomized (1:1), multicenter, double-blind, placebo-controlled trial in 403 patients with extensive-stage small cell lung cancer who received no prior chemotherapy for extensive stage disease and had ECOG performance status 0 or 1.”

    Go to full article published by The ASCO Post on March 19, 2019.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt:

    “Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues.

    “The announcement comes after Roche in September said patients with untreated extensive-stage small cell lung cancer (SCLC) lived a median 12.3 months after getting the Tecentriq cocktail, compared to 10.3 months for those getting chemotherapy alone.

    “Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18, the drugmaker said in a statement.”

    Go to full article published by Reuters on Dec 4, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt:

    “On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

    “Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.”

    Go to full article published by the U.S. Food and Drug Administration on Oct 16, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt from The ASCO Post:

    “Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response.

    “This approval for nivolumab had been granted Priority Review from the FDA. It was based on data from the SCLC cohort of the ongoing phase I/II CheckMate-032 study evaluating nivolumab monotherapy in patients who experienced disease progression after platinum-based chemotherapy.”

    Go to full article published by The ASCO Post on Aug 17, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt from The ASCO Post:

    “Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

    “Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study.”

    Go to full article published by The ASCO Post on Aug 20, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt:

    “ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”

    Go to full article published by The ASCO Post on Aug 9, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt from Healio:

    “The FDA granted priority review designation to a supplemental biologics license application that seeks approval of pembrolizumab for use in combination with chemotherapy as first-line treatment of metastatic squamous non-small cell lung cancer regardless of PD-L1 expression.

    “The agency set a target action date of Oct. 30.”

    Go to full article published by Healio on July 2, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt from OncLive:

    “The FDA has approved enzalutamide (Xtandi) for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to Pfizer and Astellas, the codevelopers of the antiandrogen agent.

    “The approval is based on the phase III PROSPER trial, in which the combination of enzalutamide (Xtandi) and androgen deprivation therapy (ADT) reduced the risk of metastases or death by 71% compared with ADT alone for patients with nonmetastatic CRPC. In the double-blind study, the median metastasis-free survival (MFS) was 36.6 months with enzalutamide plus ADT versus 14.7 months with ADT alone (HR, 0.29; 95% CI, 0.24-0.35; P <.0001).”

    Go to full article published by OncLive on July 13, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

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    Proposed FDA “Conditional Approval”- More Details

    With: Marty Tenenbaum, PhDAl Musella, DPM

    A Q&A with Al Musella, DPM, President, Musella Foundation For Brain Tumor Research & Information, Inc., Hewlett, NY, and Marty Tenenbaum, PhD, Founder and Chair, Cancer Commons, Los Altos, CA Originally published May 10, 2017 Q: Your April 5, 2017 blog post that proposed a new “Conditional” category for FDA drug approval elicited a number of positive and negative responses. Please explain the proposal in more detail… Read more »