Merus NV gained accelerated U.S. FDA approval of Bizengri (zenocutuzumab) as the first and only targeted therapy indicated for NRG1-positive pancreatic adenocarcinoma and non-small-cell lung cancer patients with advanced unresectable or metastatic disease. The approval comes about seven months after the FDA accepted the BLA for filing under priority review, and one month after the agency extended the PDUFA goal date to Feb. 4, 2025. It is the first approved therapeutic for Merus, which is based in both Utrecht, the Netherlands, and Cambridge, Mass., but its label contains a boxed warning for embryo-fetal toxicity. Bizengri will be available in the coming weeks, as Merus entered a commercial U.S. partnership on Dec. 2 with Partner Therapeutics Inc.

NMPA clears drugs from Innovent/Hutchmed, Hengrui, Henlius, Luye

China’s National Medical Products Administration (NMPA) granted new approvals to several Chinese biopharmaceuticals this week, including expanding indications of four different cancer drugs and clearing one sublingual tablet for stroke.

Protara soars, CG tepid on bladder cancer data

Shares of Protara Therapeutics Inc. (NASDAQ:TARA) were trading at $6.95, up $3.41, or 96%, on results from its ongoing phase II open-label Advanced-2 trial. The trial is testing the intravesical cell-based TARA-002 in high-risk non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ or CIS (±Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-naïve. Ta indicates the cancer has reached the innermost layer of the bladder lining; and T1 means the cancer has started to grow into the connective tissue beneath the lining. The complete response (CR) rate across BCG exposures was 72% (13/18) at six months and 70% (14/20) at any time with 100% (9/9) of patients maintaining a CR from three months to six months, Protara said. Two of three patients maintained a CR at nine months. The results were featured today during a poster session at the annual meeting of the Society of Urologic Oncology in Dallas. At the same meeting, CG Oncology Inc. unveiled top-line data from the phase III Bond-003 trial in BCG-unresponsive high-risk NMIBC patients who were given the company’s cretostimogene grenadenorepvec. Results show that 74.5% of patients achieved a CR at any time after getting the drug as a single agent. The median duration of response has not been reached but exceeds 27 months as of the data cutoff of Sept. 30, CG said. The drug is a recombinant oncolytic adenovirus encoding the immunohematopoietic cytokine granulocyte-macrophage colony stimulating factor. The firm’s stock (NASDAQ:CGON) did not react as much as Protara’s, selling for $34.34, down $1.58.

US FDA looks at how to flex new accelerated approval authorities

Seeking accelerated approval as a fallback when clinical evidence is not quite strong enough for traditional approval could be a practice of the past. In new draft guidance, the U.S. FDA repeatedly stresses that drug sponsors considering accelerated approval should discuss it with agency staff early in the candidate’s development program. The guidance also explains how the agency plans to exercise some of the new authorities and responsibilities Congress gave it last year to rein in perceived abuses of the accelerated pathway. That includes expediting withdrawal of such approvals when sponsors fail to conduct the required confirmatory trials, the trial fails to verify efficacy or benefit, safety issues arise, or the sponsor promotes the drug in a false or misleading manner.

Estrous cycle alters murine breast cancer response to chemotherapy

In breast cancer, neoadjuvant chemotherapy reduces the tumor before surgery. However, the response to this treatment does not depend solely on the subtype of malignancies. Other factors could play a key role in its effectiveness, as shown in a study that described how the estrous cycle phases contribute to this variation. The researchers propose adjusting the approach to the most suitable moment for patients.

Also in the news

Akeso, Allay, Amarna, Antag, Astrazeneca, Atea, Biocardia, Biogene, Biopharmaceutical Research, Can-Fite, Cartography, Dewpoint, Eli Lilly, Ensysce, Everest, Evommune, Foresee, GSK, Hemostemix, Impact, Ionis, Leo, Martin, Mitsubishi Tanabe, Neurosense, Northx, Outlook, Preveceutical, Refoxy, Relmada, Revolution, Rgenta, Rondo, Scitech, Servatus, Simcere, Stoke, TC Biopharm, Teva, Theratechnologies, Thermosome, Trevi, Vincerx, Vivavision