Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) following platinum-based chemotherapy. The only approved targeted oral treatment for NSCLC with EGFR exon20ins, the therapy received a priority review and breakthrough therapy designation from the FDA. The accelerated approval is based on overall response rate and duration of response, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

More results with Exelixis CRC therapy zanzalintinib to come

Safer and more efficacious therapies for colorectal cancer have been sought by developers for years, and Exelixis Inc.’s positive phase III top-line data June 22 with zanzalintinib (zanza) is providing hope. Alameda, Calif.-based Exelixis offered findings from the Stellar-03 pivotal experiment with zanza combined with PD-L1 blocker Tecentriq (atezolizumab, Roche AG), which turned up a statistically significant improvement in overall survival vs. regorafenib, the oral multi-kinase inhibitor first approved by the U.S. FDA in the hands of Bayer AG. More zanza data are likely to emerge soon. The compound is included on Clarivate’s 2025 Drugs to Watch list.

Chemotherapy-induced mutations are not universal phenomenon

The first systematic whole genome sequencing study of how chemotherapy damages healthy tissues has shown that many, but not all, of these agents cause mutations and premature aging of normal blood cells. Substantial additional somatic mutation loads – with characteristic mutational signatures – were imposed by some chemotherapeutic agents, but the effects were dependent on the drug and blood cell types. Knowing drugs in the same class carry a different risk of causing mutations in healthy tissues opens the way to minimizing collateral damage at the time of treatment, and of factoring in the risk of promoting future cancers.

FDA nods and deals fail to lift cancer stocks Verastem, Nextcure, Iovance

After falling 4.74% in the first quarter (Q1), the BioWorld Cancer Index (BCI) staged a strong recovery in Q2, ending the period up 12.78%. The broader markets followed a similar trajectory, with the Dow Jones Industrial Average rebounding from a 4.41% loss at the end of April to close Q2 with a 3.64% gain. The Nasdaq Biotechnology Index also improved, trimming its earlier 5.37% decline to finish June down just 1.92%. Despite overall gains, 12 companies on the BCI saw their stocks fall in Q2. The largest decliners on the BCI in the quarter were Iovance Biotherapeutics Inc. (down 48%), Casi Pharmaceuticals Inc. (down 45%), Verastem Inc. (down 31%) and Allogene Therapeutics Inc. (down 23%).

Researchers arm CAR T cells to fight solid tumors

Aussie researchers have used CRISPR gene editing tools to “armor” chimeric antigen receptor (CAR) T cells to activate additional cancer-fighting proteins at the tumor site, enabling them to target cancer cells in solid tumors. Researchers at Australia’s Peter MacCallum Cancer Center in Melbourne said during a July 2 media briefing that these modified CAR T cells have the potential to treat many common types of cancer, including breast, colon and ovarian cancer. In fact, cure rates in their tests on mice with solid tumors were close to 100%.

New US working group to step up FCA enforcement

The U.S. Health and Human Services (HHS) and the Justice Departments are bringing more resources to their crack down on False Claims Act (FCA) violations involving drugs, medical devices and Medicare fraud. The two departments have formed a new working group to maximize their coordination, expedite investigations and identify new leads. Besides continuing to rely on whistleblowers, the working group plans to use enhanced mining of HHS data and assessment of HHS report findings to flag possible violations.

Holiday notice

BioWorld's offices will be closed in observance of Independence Day in the U.S. No issue will be published Friday, July 4.

Also in the news

Abeona, AN Venture Partners, Arrivent, Bio-Thera, Casinvent, Channel, Cue, Curanex, Curis, Eyenovia, Ferring, Genenta, Hikma, Hyperion Defi, Ligand, Lixte, Mabxience, Merck, Organon, Oruka, Pneumagen, Primo, Ribocure, Vesper, Vyne