Oncology

Theratechnologies (NSDQ:THTX) announced that the peer-reviewed journal Cancer Science had published its preclinical research related to TH1902, a peptide linked to the chemotherapeutic agent docetaxel. The research tested the investigational drug as a sortilin-positive triple-negative breast cancer (TNBC) treatment. TNBC lacks the expression or amplification of targetable biomarker. The prognosis for this cancer subgroup tends…

Gilead (NSDQ:GILD) subsidiary Kite will collaborate with Appia Bio (Culver City, Calif.) to develop engineered allogeneic cell therapies from hematopoietic stem cells (HSCs) for cancer patients.  To that end, they have entered into a collaboration and license agreement to develop HSC-derived cell therapies for hematological malignancies.  Under the agreement, Appia Bio will lead preclinical and…

Sanofi (NSDQ:SNY) may be one of the biggest vaccine manufacturers in the world, but the quick rise of the mRNA vaccine platform during the pandemic caught the company by surprise.  The company could be on the way to rectify that with its $3.2 billion acquisition of its mRNA partner Translate Bio.  Sanofi began working with…

FDA has granted orphan drug designation for Novartis’s (SWX:NOVN) NIS793, an anti-TGF-β IgG2 monoclonal antibody. Specifically, the designation covers the use of NIS793 in conjunction with standard-of-care chemotherapy to treat pancreatic cancer. NIS793 has been the subject of eight clinical trials for indications ranging from solid tumors to myelofibrosis. NIS793 would be a first-in-class antibody specific…

Merck (NYSE:MRK) announced today that it received FDA approval for Keytruda for treating high-risk, early-stage, triple-negative breast cancer (TNBC). Kenilworth, N.J.-based Merck’s Keytruda anti-PD-1 therapy received approval for use in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery, according to a news release. Approval was based…

With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications, we face the dawn of a new era in anticancer research. New therapeutic targets, novel classes of products, booming and competing pipelines, innovative statistical methods, and a changing regulatory environment are all features of this…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Asparlas from Servier Pharmaceuticals is an asparagine-specific enzyme that is FDA-indicated as a treatment for acute lymphoblastic leukemia in patients aged one month to 21 years. In 2018, FDA approved the drug for use as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL).

Tukysa from Seagen won FDA approval for HER2-positive breast cancer in conjunction with chemotherapy (trastuzumab and capecitabine) to treat advanced unresectable or metastatic HER2-positive breast cancer. The indication covers patients with brain metastases who previously received anti-HER2-based therapies for metastatic cancer.

Lorbrena from Pfizer was initially FDA indicated to treat adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive based an FDA-approved test. In March, Pfizer announced that the drug had won an expanded indication for use as a first-line therapy for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell…

Braftovi Mektovi from Array BioPharma won FDA approval in 2018 for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Pfizer acquired Array BioPharma in 2019. Braftovi Mektovi is an example of a BRAF/MEK inhibitor combination. The BRAF gene supports chemical signaling between the cell’s nuclear and the cell’s exterior. The MEK…

Piqray from Novartis is FDA indicated to treat hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. The FDA indication requires the use of an FDA-approved test following progression on or after an endocrine-based regimen.

Orgovyx from Myovant Sciences is a gonadotropin-releasing hormone receptor antagonist that is FDA indicated to treat adults with advanced prostate cancer. FDA approved the drug in December 2020. In a press release, Richard Pazdur, FDA’s acting director of the Office of Oncologic Diseases, noted that ORGOVYX is “the first oral drug in this class and it…

FDA has indicated Merck‘s Recarbio for infections resulting from susceptible gram-negative microorganisms. The drug combines imipenem (a penem antibacterial), cilastatin (a renal dehydropeptidase inhibitor) and relebactam (a beta-lactamase inhibitor). Current FDA indications for the drug include hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, complicated urinary tract infections and complicated intra-abdominal infections.

FDA has indicated Karyopharm Therapeutics‘ nuclear export inhibitor Xpovio for relapsed or refractory multiple myeloma (RRMM). The indication covers its use in conjunction with the steroid dexamethasone. Patients receiving the drug should receive at least four previous therapies. Furthermore, the indication covers patients with myeloma that is refractory to at least two proteasome inhibitors, two immunomodulatory agents and…

Pemazyre (pemigatinib) from Innovent Biologics is a novel treatment for cholangiocarcinoma, a type of bile duct cancer. The indication covers unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement. Innovent continues to roll the drug out throughout the world. In June, it won regulatory approval in Taiwan…

ROZLYTREK from Roche‘s Genentech division is FDA-indicated for adult patients with metastatic non-small cell lung cancer whose tumors are ROS1-positive. In addition, it is indicated for adults and children 12 and older with solid tumors. The latter indication requires that the tumors have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation. Other requirements…

FDA has approved TAZVERIK from Epizyme for multiple indications. The first-in-class EZH2 inhibitor is now indicated for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. The drug is also indicated for adults with relapsed or refractory follicular lymphoma whose tumors are positive for…

Qinlock (ripretinib) is indicated to treat adult patients with advanced gastrointestinal stromal tumors (GIST). The drug from Qinlock won FDA approval on May 15, 2020. In the Phase 3 INVICTUS study, the drug demonstrated clinical benefits with dose escalation for patients with advanced gastrointestinal stromal tumors with disease progression.      

FDA has indicated Gavreto (pralsetinib) from Blueprint Medicines to treat adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC). The drug was formerly known as BLU-667 and won FDA approval in September 2020. CStone, which is developing the drug in China, received approval from that country’s regulatory authority, making it the first novel therapy for…

Ayvakit from Blueprint Medicines Corp. was initially FDA-indicated to treat adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations. In June, the drug won expanded use to include advanced systemic mastocytosis based on data from the single-arm, open-label EXPLORER and PATHFINDER clinical studies.…

Bayer‘s Vitrakvi is a kinase inhibitor that is FDA indicated to treat adult and pediatric patients with solid tumors. Specifically, FDA indicates it for solid tumors with the following criteria: Presence of a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. Metastatic or where surgical resection is likely to result in severe morbidity.…

FDA indicates Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer. Bayer and Orion Corp. jointly developed the drug, which FDA approved in 2019. The approval came after FDA reviewed results from the Phase 3 ARAMIS study, which tested Nubeqa with androgen deprivation therapy (ADT) in patients with prostate cancer. The drug has continued to…

Xospata (gilteritinib) from Astellas Pharma is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. In March, Astellas announced that the drug met its primary endpoint in a planned interim analysis of a Phase 3 confirmatory…

Lutathera from Novartis is indicated to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, which include foregut, midgut and handout neuroendocrine tumors in adults. The drug was the focus of a recent presentation World Congress on Gastrointestinal Cancer 2021 where Dr. Jonathan R. Strosberg, presented positive survival data concerning the drug. Strosberg is the head of the Neuroendocrine Tumor…