HONG KONG – Lutris Pharma Ltd., a company taking on the dermal toxicity common to cancer therapy with EGFR inhibitors, has begun testing its lead product, the B-Raf inhibitor LUT-014, in a phase II trial targeting reduction of acne-like lesions associated with the class. Partial results are expected by the end of 2021.
Shares of Biolinerx Ltd. (NASDAQ:BLRX) shot up 53% to $4.88 May 4 on news that adding its lead candidate, motixafortide, to standard of care G-CSF for hematopoietic stem cell mobilization helped achieve significantly better mobilization than G-CSF alone in a phase III trial. The company said it's working "aggressively" to gain regulatory approval to market the drug for use in autologous bone marrow transplants for multiple myeloma (MM) patients, with plans to make an NDA submission in the first half of 2022.
While last week’s marathon Oncologic Drugs Advisory Committee meeting to consider accelerated approvals for cancer drugs that didn’t demonstrate effectiveness in confirmatory trials was a good step forward, oncologists need the FDA to do more to ensure drug labeling truly reflects the benefit of the product.
LONDON – In what is claimed as the largest series A for a Danish biotech, Adcendo ApS has raised €51 million (US$61.3 million) to take forward antibody-drug conjugate (ADC) drugs aimed at proprietary targets that are involved in cellular recycling processes.
Vaccitech plc and Werewolf Therapeutics Inc. opened the last day of April with contrasting IPOs. Both priced mid-range, with Vaccitech raising $110.5 million, similar to Werewolf's $120 million haul. However, American depository shares of Vaccitech (NASDAQ:VACC), co-developer of Astrazeneca plc’s COVID-19 vaccine, fell 17.1% to $14.10 from a $17 open, while shares of cancer therapy developer Werewolf (NASDAQ:HOWL) boomed – until they didn't – climbing to $24 before closing about where they started, at $16.10.
The FDA’s Oncologic Drugs Advisory Committee voted 6-2 April 29 to recommend withdrawing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a third-line treatment for a subgroup of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer. The vote was based on FDA assurances that, if it withdrew the approval, it would work with Merck to delay the withdrawal or set up an access program to ensure the estimated 1,000 patients who are beyond first-line treatment could still get Keytruda.
In the final part of its three-day meeting on accelerated approvals granted to anti-PD-1/PD-L1 antibodies, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted unanimously to continue the accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) as a therapy for patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar, Bayer AG).
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.
If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.
In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed.
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