Showing posts from December, 2020

US FDA accepts and grants priority review status to Pfizer’s sNDA for Lorbrena to treat ALK-positive metastatic NSCLC

Pfizer announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for Lorbrena (lorlatinib) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2021. Lorbrena is a third-generation ALK inhibitor specifically developed to inhibit the most common tumor mutations that drive resistance to current medications and to address brain metastases. Up to 40% of people with ALK-positive lung cancer present with brain metastases. “The decision by the FDA to evaluate our application for Lorbrena under its innovative review pathways, which aim to speed up availability of potentially life-changing medicines, underscor

Roche gets EC nod for Phesgo to treat HER2-positive breast cancer

Roche has secured approval from the European Commission (EC) for its Phesgo to treat early and metastatic HER2-positive breast cancer. Phesgo is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase designed to be used as subcutaneous (SC) injection. Phesgo integrates the same monoclonal antibodies as Perjeta and Herceptin with Halozyme Therapeutics’ Enhanze drug delivery technology in a novel formulation for SC use. Phesgo, which is available as a single-dose vial for SC injection, enables more than 90% faster treatment than IV administration of standard of care therapy with Perjeta and Herceptin. The regulator approved Phesgo based on data from the pivotal phase III FeDeriCa study, which demonstrated that treatment with Phesgo generated non-inferior levels of Perjeta and Herceptin in the blood and shown comparable efficacy versus intravenous (IV) administration of the two medicines, said the company. FeDeriCa is an international, multi-centre

Myovant Up on $4.2B Pfizer Pact to Develop Prostate-Cancer Drug

Myovant Sciences ( MYOV ) - Get Report was higher Monday after the biopharma and Pfizer ( PFE ) - Get Report said they would collaborate on a prostate-cancer treatment, an agreement valued at as much as $4.2 billion. Shares of the Switzerland-based company at last check were climbing 19% at $27.10. Pfizer, the New York health-care giant, was up 0.4% at $37.41. Under the agreement, the companies will develop and commercialize Myovant’s Orgovyx in advanced prostate cancer and, if approved, a combination tablet that includes relugolix, the active ingredient in Orgovyx, in women’s health in the U.S. and Canada. The U.S. Food and Drug Administration has approved Orgovyx, generically relugolix, to treat adults with advanced prostate cancer. The FDA is reviewing the combination tablet for women with uterine fibroids, with the agency targeted to take action on the matter June 1. The combination tablet is also under development for women with endometriosis. A new-drug application is expec

Astellas Reports XOSPATA® (gilteritinib) in Combination with Azacitidine Did Not Meet Endpoint of Overall Survival in Newly Diagnosed FLT3 Mutation-Positive Acute Myeloid Leukemia Patients Ineligible for Intensive Induction Chemotherapy

Astellas Pharma Inc.  today announced that a Phase 3 trial of XOSPATA® (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial. An independent Data Monitoring Committee recommended terminating the study for futility, concluding results are unlikely to show a statistically significant increase in overall survival. Astellas has stopped enrollment in the trial and is reviewing the results for other action as needed. "Although we are disappointed by the primary outcome of LACEWING, we are conducting a thorough review of the data and plan to share detailed results at a later date," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "These results do not affect other ongoin

New DARZALEX (daratumumab) Data from GRIFFIN Study Show Deeper and Longer Responses in Patients with Newly Diagnosed Multiple Myeloma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from the randomised Phase 2 GRIFFIN study showing that the addition of DARZALEX®▼ (daratumumab) to lenalidomide, bortezomib and dexamethasone (D-RVd), followed by daratumumab plus lenalidomide (D-R) maintenance therapy, resulted in deeper and improved responses, including minimal residual disease (MRD) negativity, compared to RVd followed by R alone, in newly diagnosed, stem cell transplant-eligible patients with multiple myeloma.1 These data investigating the use of daratumumab in combination with RVd, which were shared in separate oral and poster presentations at the American Society of Hematology (ASH) 2020 Annual Meeting, provide further evidence that this regimen may provide greater efficacy for transplant-eligible, newly diagnosed multiple myeloma (NDMM) patients than standard therapy. This morning’s oral presentation (Abstract #549) shared longer-term follow-up data, and the poster presentation (Abs

Merck, Artios Pharma Collaborate To Discover, Develop Multiple Precision Oncology Drugs

  Merck and Artios Pharma Limited have recently announced a global three year strategic research collaboration to discover and develop multiple precision oncology drugs. "Our platform has the potential to revolutionize targeted treatment in cancer and deliver on the promise of precision medicine. This collaboration will leverage the potential of our unique discovery platform of novel DNA repair nuclease inhibitors and targets that we have been developing. The partnership puts us in an exceptional position to focus internal efforts on our leading portfolio of assets which includes a small-molecule ATR inhibitor and a Polθ programme, both in candidate IND evaluation," said Niall Martin, Chief Executive Officer at Artios Pharma. Targeting DNA damage response has the potential to provide an important therapeutic option for many patients in need of new treatments. We are excited about working with Artios to develop novel precision oncology medicines as we move towards changing the

PharmaEngine, Sentinel Oncology ink collaboration and licensing pact to advance development of Chk1 inhibitor, SOL-578

PharmaEngine Inc, a commercial stage oncology company, announced that it has entered into a collaboration and license agreement with UK-based Sentinel Oncology Limited for advancing the new drug development of SOL-578, a Checkpoint Kinase 1 (Chk1) inhibitor, under which PharmaEngine will fund the IND enabling studies for SOL-578. Sentinel Oncology Limited is a drug discovery company developing novel therapeutics to treat cancer patients. The company's mission is to increase survival and improve outcomes for cancer patients with CNS tumors. SOL-578 is a best-in-class checkpoint kinase 1 (Chk1) inhibitor featuring high kinase selectivity and oral bioavailability which targets the DNA Damage Response (DDR) network. Under the terms of the agreement, Sentinel Oncology will receive an exclusivity payment and PharmaEngine will obtain an option to receive the exclusive rights to develop and commercialize SOL-578 worldwide. In the event that PharmaEngine completes the IND enabling studies