Oncology

The FDA has granted accelerated approval to the first-in-class antibody-drug conjugate Tivdak (tisotumab vedotin-tftv) from Genmab and Seagen to treat adults with recurrent or metastatic cervical cancer. Specifically, the approval covers cancer with disease progression on or after chemotherapy. The drug targets protein tissue factor (TF), which is abnormally expressed in cervical cancer. Historically, physicians…

Ivy Brain Tumor Center and its partner Sonalasense have announced positive initial results in a first-in-human Phase 0/1 clinical trial involving recurrent glioblastoma patients. Sonalasense has developed a noninvasive sonodynamic therapy (SDT) that pairs low-intensity ultrasound with chemotherapeutic agents known as sonosensitizers. The therapy is noninvasive. Data from the trial indicate that SDT swiftly causes…

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. Just one example: the mortality rate for Black women with breast cancer is 40% higher than…

Immunotherapy-specialist Hookipa Pharma (NSDQ:HOOK) has announced a clinical collaboration and supply agreement with Merck (NYSE:MRK). Hookipa will test its immunotherapeutic HB-200 in conjunction with Merck’s blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), as first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC). Last year, Merck raked in $14.5 billion in sales revenue from Keytruda.…

Sanofi (NSDQ:SNY) announced today that it has completed the purchase of its mRNA partner Translate Bio. The previously announced deal, according to Sanofi, accelerates the French pharma giant’s efforts to develop transformative vaccines and therapies using mRNA technology. The deal comes during a year in which mRNA-based Moderna (NSDQ:MRNA) and Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccines are…

AB Science today touted results from a study of masitinib in combination with docetaxel in treating prostate cancer. Paris-based AB Science presented the data at the 2021 American Urological Association (AUA) annual meeting, according to a news release. Masitinib in combination with docetaxel as a first-line treatment of metastatic castrate refractory prostate cancer (mCRPC) eligible…

AstraZeneca (LON: AZN) announced that Imfinzi (durvalumab) together with tremelimumab and platinum-based chemotherapy improved overall survival by 23% and progression-free survival by 28% compared to chemotherapy alone in patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). The data came from a Phase 3 trial known as POSEIDON. Imfinzi and tremelimumab are immune checkpoint…

A multi-year partnership between Janssen Research & Development (NYSE: JNJ) and ConcertAI (Cambridge, Mass.) will focus on using real-world data and AI for oncology applications involving multiple cancer types. ConcertAI will work “almost an extension of [Janssen’s] R&D development process,” said Jeff Elton, CEO of the company. The two companies’ teams will work closely together…

Roche (OTCQX:RHHBY) has voluntarily withdrawn its application for FDA accelerated approval for the monoclonal antibody Tecentriq (atezolizumab) in combination with chemotherapy to treat unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) with tumors expressing programmed death-ligand 1 (PD-L1). Earlier this month, Roche won priority review for Tecentriq for people with non-small cell lung cancer…

Biopharma iBio, Inc. (NYSEA:IBIO) has entered into a definitive global exclusive license agreement with RubrYc Therapeutics for RTX-003, an immunotherapy candidate targeting regulatory T cells. In addition, the deal includes an option for iBio to license additional antibodies designed with RubrYc’s antibody discovery platform based on machine learning and computational biology. iBio made an upfront $5 million…

The U.S. Court of Appeals for the Federal Circuit tossed a $1.2 billion fine against Gilead Sciences after invalidating portions of a Memorial Sloan Kettering Cancer Center patent licensed to a Bristol Myers Squibb subsidiary. The patent was the basis for the previous ruling against Foster City, Calif.–based Gilead, which related to patent infringement claims…

Focused on antibody-based cancer therapies, Zymeworks (NYSE:ZYME) believes bi- and multi-specific antibodies offer significant potential in oncology. Such therapies could provide new biological avenues for cancer treatment and extend immunotherapy to patients with few options. The FDA has approved three bispecific antibodies, and more than one hundred others are in development across the industry. Zymeworks…

Novartis (NYSE:NVS) has announced that the FDA has granted priority review for its application for allosteric inhibitor asciminib (ABL001) in chronic myeloid leukemia (CML). The drug targets the ABL myristoyl pocket (STAMP). The priority review status could trim four months off the review time, dropping the review period to eight months from 12 months under a…

Novartis (SWX:NOVN) has announced that the genetically modified autologous T cell immunotherapy Kymriah (tisagenlecleucel) failed to meet the primary endpoint in its Phase 3 BELINDA trial. That endpoint involved event-free survival for people with aggressive B-cell non-Hodgkin lymphoma compared to standard of care. To qualify for the study, patients needed to have primary refractory disease…

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…